Full text
EXHIBIT 8
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 1 of 60 PageID#
2516
From:
John Thomas
Sent:
Tuesday, March 24, 2020 9:30 AM PDT
To:
Wong, Michael@DGS
BCC:
Browning, Abby@CalOES; Mike Gula; Jennilee Brown
Subject:
Re: Medical Supplies Sheet
Attachments:
N95-Foldable.zip, GZ Harley (1).zip, Wondfo SARS-CoV-2 Antibody test (lateral flow method).zip
Dear Michael,
Is this what you mean for specs? Please see attached.
Can you provide me with a rough estimate of much and by when you need it I can start shuffling
around things on my end now to make sure we can get you what you need?
Thanks!
John
On Mon, Mar 23, 2020 at 9:43 PM John Thomas <john@blueflame.agency> wrote:
Thanks, Michael. Yes I have all the spec sheets I'll package up.
We can do a 75% prepayment and the balance upon receipt. I have to give them pre-payment
but you have the 48 hour inspection period or you can reject the goods and you get a refund.
Also I just got word from my lead manufacturer that we need to place an order for 100mil n95
masks or they will sell them to the UK. I HIGHLY suggest we lock them in now. We can have
you place a deposit on the 100mil mask order to make sure the inventory doesn't disappear and
then do the usual 75% prepayment per lot that gets shipped over time.
I'm happy to show you the text messages back and forth to this manufacturer. We literally have
9 hours to make this call on the masks. I strongly encourage that you move on this one.
Thanks again. As always I'm available 24/7.
John
On Mon, Mar 23, 2020 at 6:52 PM Wong, Michael@DGS <Michael.Wong@dgs.ca.gov>
wrote:
John, do you have specification sheets for the N95 masks and the COVID19 test kits?
Also, what other options do we have for payment to foreign manufacturers?
Respectfully,
a
EXHIBIT
Plaintiffs 1
E
•
CONFIDENTIAL
BFM000116042
From:
John Thomas
Sent:
Tuesday, March 24, 2020 9:30 AM PDT
To:
Wong, Michael@DGS
BCC:
Browning, Abby@CalOES; Mike Gula; Jennilee Brown
Subject:
Re: Medical Supplies Sheet
Attachments:
N95-Foldable.zip, GZ Harley (1).zip, Wondfo SARS-CoV-2 Antibody test (lateral flow method).zip
Dear Michael,
Is this what you mean for specs? Please see attached.
Can you provide me with a rough estimate of much and by when you need it I can start shuffling
around things on my end now to make sure we can get you what you need?
Thanks!
John
On Mon, Mar 23, 2020 at 9:43 PM John Thomas <john@blueflame.agency> wrote:
Thanks, Michael. Yes I have all the spec sheets I'll package up.
We can do a 75% prepayment and the balance upon receipt. I have to give them pre-payment
but you have the 48 hour inspection period or you can reject the goods and you get a refund.
Also I just got word from my lead manufacturer that we need to place an order for 100mil n95
masks or they will sell them to the UK. I HIGHLY suggest we lock them in now. We can have
you place a deposit on the 100mil mask order to make sure the inventory doesn't disappear and
then do the usual 75% prepayment per lot that gets shipped over time.
I'm happy to show you the text messages back and forth to this manufacturer. We literally have
9 hours to make this call on the masks. I strongly encourage that you move on this one.
Thanks again. As always i'm available 24/7.
John
On Mon, Mar 23, 2020 at 6:52 PM Wong, Michael@DGS <Michael.Wong@dgs.ca.gov>
wrote:
John, do you have specification sheets for the N95 masks and the COVID19 test kits?
Also, what other options do we have for payment to foreign manufacturers?
Respectfully,
BFM000116042
CONFIDENTIAL
exhibitsticker.com
EXHIBIT
Plaintiff's 1
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 2 of 60 PageID#
2517
Plaintiff's
Trial Exhibit
48
Ake/ t4
Contracts Administrator
Phone: 916-441-9619
Email: Michael.Wong@dgs.ca.gov
DGS PROCUREMENT
Beware of Fraudulent Activity! — DGS has recently been made aware of fraudulent Purchase Orders and Spoof emails issued
to the vendor community. Always confirm the validity of any Purchase Order by contacting the agency making the request. Do
not process any order that appears suspicious. Do not click on any hyperlinks from a suspicious email. A list of State agency
contact information is provided on the DGS website located at http://www.dgs.ca.gov/pd/Programs/Delegated.aspx. Be vigilant
by confirming valid State of California emails and phone numbers at https://cold.govops.ca.gov/. Vigilance is everyone's
responsibility. For more information please visit http://www.dgs.ca.gov/pd/Home/FRAUDALERT.aspx.
From: John Thomas [mailto:iohn@blueflame.agency]
Sent: Monday, March 23, 2020 6:38 PM
To: Wong, Michael@DGS <Michael.Wong@dgs.ca.gov>
Subject: Medical Supplies Sheet
CAUTION: This email originated from a NON-State email address. Do not click links or open attachments unless
you are certain of the sender's authenticity.
Dear Michael,
Pleasure texting with you. Here's our sales sheet for today. I have some inventory in california,
some in Mexico and a huge global supply chain that can service any need you have going
forward.
Hand sanitizer I just came into a bunch of inventory of hand sanitizer based here in Riverside,
California that is 80% alcohol levels. Also we can make children's n95 masks now at about 9
mil units a month. This isn't on the sales sheet.
CONFIDENTIAL
BFM000116043
Michael Wong
Contracts Administrator
Phone: 916-441-9619
Email: Michael.Wong@dgs.ca.gov
Beware of Fraudulent Activity! – DGS has recently been made aware of fraudulent Purchase Orders and Spoof emails issued
to the vendor community. Always confirm the validity of any Purchase Order by contacting the agency making the request. Do
not process any order that appears suspicious. Do not click on any hyperlinks from a suspicious email. A list of State agency
contact information is provided on the DGS website located at http://www.dgs.ca.gov/pd/Programs/Delegated.aspx. Be vigilant
by confirming valid State of California emails and phone numbers at https://cold.govops.ca.gov/. Vigilance is everyone’s
responsibility. For more information please visit http://www.dgs.ca.gov/pd/Home/FRAUDALERT.aspx.
From: John Thomas [mailto:john@blueflame.agency]
Sent: Monday, March 23, 2020 6:38 PM
To: Wong, Michael@DGS <Michael.Wong@dgs.ca.gov>
Subject: Medical Supplies Sheet
CAUTION: This email originated from a NON-State email address. Do not click links or open attachments unless
you are certain of the sender’s authenticity.
Dear Michael,
Pleasure texting with you. Here's our sales sheet for today. I have some inventory in california,
some in Mexico and a huge global supply chain that can service any need you have going
forward.
Hand sanitizer I just came into a bunch of inventory of hand sanitizer based here in Riverside,
California that is 80% alcohol levels. Also we can make children's n95 masks now at about 9
mil units a month. This isn't on the sales sheet.
DGS Procurement,
BFM000116043
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 3 of 60 PageID#
2518
75,000 6oz units that we can private label.
1 mil bottles of 2oz hand sanitizer.
If you want I can have this moved to you tomorrow.
Please let me know what the next steps are.
Thanks again!
John
John Thomas
President
Blueflame Strategies
c. (818) 636-6522
e. john@blueflame.agency
LI
John Thomas
President
Blueflame Strategies
c. (818) 636-6522
e. john@blueflame.agency
CONFIDENTIAL
BFM000116044
75,000 6oz units that we can private label.
1 mil bottles of 2oz hand sanitizer.
If you want I can have this moved to you tomorrow.
Please let me know what the next steps are.
Thanks again!
John
--
John Thomas
President
Blueflame Strategies
c. (818) 636-6522
e. john@blueflame.agency
--
John Thomas
President
Blueflame Strategies
c. (818) 636-6522
e. john@blueflame.agency
BFM000116044
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 4 of 60 PageID#
2519
John Thomas
President
Blueflame Strategies
c. (818) 636-6522
e. john@blueflame.agency
CONFIDENTIAL
BFM000116045
--
John Thomas
President
Blueflame Strategies
c. (818) 636-6522
e. john@blueflame.agency
BFM000116045
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 5 of 60 PageID#
2520
1221121.2
u.nroLy
A
C
O
E
C
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a.)
C
O
U
IgG
t First infection
t Second infection
Order information
Wondfo®
As an auxiliary and supplementary method for the
further diagnosis to the patients with negative
result in PCR.
Easy to use, instant result in 15 minutes
According to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (r" Edition)
published by general office of national health committe, serology testing can be used as a
diagnostic method of COVI D-19 infection.
Antibodies can be detected as early as one
week after infection, with slightly difference
between individuals.
1. Negative result indicates no infection or
infection at a very early stage (within first
few days).
2. Positive result indicates an infection with
coronavirus.
Product name
Packing size
Sample type
Storage condition Shelf lif
SARS-CoV-2Antibody
Test (Lateral flow method)
20T
Whole blood,
serum and plasma
TC-30°C
6 months
Guangzhou Wondfo Biotech Co., Ltd.
Add: No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China
Websites: en.wondfo.com.cn
Wondfo
CONFIDENTIAL
BFM000116046
SARS-CoV-2 Antibody Test
(Lateral flow method)
Antibodies can be detected as early as one
week after infection, with slightly difference
between individuals.
1. Negative result indicates no infection or
infection at a very early stage (within first
few days).
2. Positive result indicates an infection with
coronavirus.
Order information
As an auxiliary and supplementary method for the
further diagnosis to the patients with negative
result in PCR.
Easy to use, instant result in 15 minutes
Concentration
First infection
IgM
IgG
IgM
Second infection
Product name Packing size Sample type Storage condition Shelf life
SARS-CoV-2Antibody
Test (Lateral flow method)
20T
Whole blood,
serum and plasma
2℃~30℃
6 months
Leading POCT Manufacturer
FOR DIAGNOSTIC USE ONLY
FOR PROFESSIONAL USE ONLY
IN VITRO
Leading POCT Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.
No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China
Tel：0086-20-32296083 Fax：0086-20-32296063
Website：www.wondfo.com.cn
4
Leading POCT Manufacturer
CONTENTS:
1. 20 individual pouches, each containing:
Test cassette
Desiccant pouch
3. Detection b
2. 20 disposable droppers
uffer(1* 6 mL)
4. Leaflet with instructions for use
(Lateral Flow Method)
SARS-CoV-2 Antibody Test
CE
CFDA
According to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (7th Edition)
published by general office of national health committe, serology testing can be used as a
diagnostic method of COVID-19 infection.
Guangzhou Wondfo Biotech Co., Ltd.
Add: No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China
Websites: en.wondfo.com.cn
0
—
BFM000116046
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 6 of 60 PageID#
2521
0011,1001111
TEIUGPM103
a
bealk
tsANn>0"..--r
.teaS,
BFM000116047
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 7 of 60 PageID#
2522
OFINC011104
CONMEKRAL
BFM000116048
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 8 of 60 PageID#
2523
COIFEEIMI.
BF1100)11100
BFM000116049
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 9 of 60 PageID#
2524
National Institute for
Occupational
o
Safet an
d Health 0
Comfortable Nose Clip
for perfect fit
protection.
,•
Blocks at least 95% of
non-oil-based airborne particles
C ON FEENTIAL
BRIO0Itl et60
National Institute for
Occupational
and Health
Comfortable Nose Clip
for perfect fit
protection.
Blocks at least 95% of
non-oil-based airborne particles
BFM000116050
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 10 of 60
PageID# 2525
CONFIDENTIAL
BFM000116051
we SERVIC
3
Fe,
>
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Disease Control
and Prevention (CDC)
Nationai Institute for Occupational
fear
NIOSH Reference: TN-19168
SafetyandHeath (NIOSH)
.
ional
Personal
Protective
P.O. Box 18070
Pittsburgh, PA 15236-0070
Phone:
412-386-4000
Fax:
412-386-4051
October 17, 2013
HEAL,
at
ite
Mr. Alexander Freedman, President
Makrite Industries Inc.
Sanax Protective Products, Inc.
105 Palmer River Road
Swansea, MA 02777
Dear Mr. Freedman:
The National Institute for Occupational Safety and Health (NIOSH) has reviewed your request
accepted May 29, 2013. This request was for an approval ofthe model SEKURA-321 filtering
facepiece air purifying respirator for protections against particulates at a N95 filter efficiency
level, reference the assembly matrix SEKURA-321AMa.xls.
This request is granted. Approval is granted only for documentation written in the English
language. It is the manufacturer’s responsibility to correctly translate materials desired in
languages other than English. The approval number TC-84A-6660 has been assigned. This
respirator is approved for protections against particulates at a N95 filter efficiency level.
The CD enclosed with this letter contains the final respirator label. The abbreviated label has
been accepted as submitted. The cautions and limitations that apply to this approval are on the
approval label. Only those assemblies affected by this request, or where new approval numbers
are assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
The approved assembly consists ofthe parts as listed on the approval label and the assembly
matrix. Parts are to be marked with the numbers indicated on the approval labels in a legible and
permanent manner (marking cannot be removed without evidence of its previous presence).
This certificate ofapproval is not an endorsement of the respirator by NIOSH, and such
endorsement shall not be stated or implied in advertisements or other publicity. However, you
may publicize the fact that the respirator has met the requirements of Title 42, Code ofFederal
Regulations, Part 84 (42 CFR 84).
BFM000116051
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 11 of 60
PageID# 2526
CONFIDENTIAL
BFM000116052
Page 2
— Mr. Alexander Freedman
— TN-19168
No changes may be made to any respirators and accompanying documentation without prior
written approval ofNIOSH. Requests for changes must be submitted to NIOSH and a
modification ofthis approval must be granted before changes are made.
Sincerely yours,
Roland BerryAnn
Acting Chief, Technology Evaluation Branch
National Personal Protective Technology Laboratory
Enclosures
BFM000116052
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 12 of 60
PageID# 2527
CONFIDENTIAL
BFM000116053
National Institute for
National Institute for Occupational Safety
and Health
Occupational Safety
and Health_| National Personal ProtectiveTechnology Laboratory
Technology Evaluation Branch
Certification, Evaluation and Festing Section
P.O. Box 18070
Pittsburgh, PA
TEST REPORT
Task Number: TN-19168
Manufacturer: Makrite Industries, Inc.
Prepared by: Jeremy Brannen
Tests Conducted by: Jeremy Brannen / Nicole Petitta
Date: July 30, 2013
Respirator Tested: SEKURA-321
Background Information
In an application accepted May 29, 2013 Makrite Industries requested an approval ofthe model
SEKURA-321 filtering facepiece air purifying respirator for protections against particulates at a
N95 filter efficiency level, reference the assembly matrix SEKURA-321AMa.xls.
Tests Assigned
Test Description
STP Number
Reference
A. Exhalation Resistance Test
RCT-APR-STP-0003
84.180
B. Inhalation Resistance Test
TEB-APR-STP-0007
84.180
C. Sodium Chloride (NACL) N95 Test
TEB-APR-STP-0059
84.181
Overall Results
The items tested passed laboratory testing.
Individual Test Results
See the attached test data sheets.
TEB-1020 Rev. 0
Page1 of 1
BFM000116053
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 13 of 60
PageID# 2528
CONFIDENTIAL
BFM000116054
National Institute for Occupational Safety and Health
hOSH
Test Data Sheet
Task Number:
TN-19168
Reference No.: CFR 84.180
Test:
Exhalation Resistance Test
STP No.:
3
Manufacturer: Makrite Industries, Inc.
Filter Type: — Filter Only
Item Tested:
SEKURA-321
Maximum Allowable Resistance
Actual Resistance
(MM of H20)
(MM of H20)
Sample
Exhalation
Exhalation
Result
1
25
10.4
PASS
2
25
10.9
PASS
3
25
8.9
PASS
Overall Result:
PASS
Comments:
()
Yes
(©)
No
Was ail equipment verified to be in calibration throughout all testing?
Signature:
dele xMitte
Date:
Engineering Technician
BFM000116054
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 14 of 60
PageID# 2529
CONFIDENTIAL
BFM000116055
National Institute for Occupational Safety and Health
Respirator Branch
losHi
Test Data Sheet
Task Number:
TN-19168
Reference No.: CFR 84.180
Test:
Inhalation Resistance Test
STP No.: 7
Manufacturer: Makrite Industries, Inc.
ltem Fested:
SEKURA-321
Filter Type:
Filter Only
Maximum Allowable Resistance
Actual Resistance
(MM of H20)
(MM of H20)
Sample
Inhalation
Inhalation
Result
I
35
13.7
PASS
2
35
11.4
PASS
|
3
35
10.2
PASS
Overall Result:
PASS
Signature:
Wide xMitte
Date:
Engineering Technician
BFM000116055
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 15 of 60
PageID# 2530
Task Number: TN-19168
Reference No.: CFR 84.180
Test:
Inhalation Resistance Test
STP No.: 7
Manufacturer: Makrite Industries, Inc.
Item Tested: SEKURA-321
Comments:
Was all equipment verified to be in calibration throughout all testing?
Q. Yes 0 No
Signature:
t gatci
Pirget
Date: 7/30/2013
Engineering Technician
Task Number:
TN-19168
Reference No.: CFR 84.180
Test:
Inhalation Resistance Test
STP No.: 7
Manufacturer: Makrite Industries, Inc.
Item Tested:
SEKURA-321
Comments:
Was ail equipment verified to be in calibration throughout alt testing?
@
Yes
©
No
Signature:
dlide,
Arbse
Date:
Engineering Technician
BFM000116056
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 16 of 60
PageID# 2531
CONFIDENTIAL
BFM000116057
National Institute for Occupational Safety and Health
Respirator Branch
OSH
Test Data Sheet
Task Number:
TN-19168
Reference No.: CFR 84.181
Test:
Sodium Chloride (NaCl)
- N95
STP No.: 59
Manufacturer: Maktrite Industries, Inc.
Item Tested:
SEKURA-321
Initial
Maximum
Initial
Maximum
Filter
Allowable
Percent
Percent
Filter | FlowRate |
Resistance —Percent Leakage
Leakage
Leakage
Result
{
85
'
13,4
5.00
1.310
1.310
|
PASS
2
85
13.8
5.00
1.360
PASS
3
85
11.6
5.00
0.578
0.588
PASS
4
85
15.3
5.00
0.800
|
0.851
PASS
5
85
13.2
5.00
0.601
0.611
PASS
6
85
5.00
0.647
PASS
7
85
|
12.9
5.00
|
0.649
0.659
PASS
g
85
15.5
5.00
0.572
0.572
PASS
9
85
112
5.00
0.298
0.317
PASS
10
| 5
13.8
5.00
0.922
0.922
PASS
|
85
14.7
5.00
0.857
PASS
12
85
11.0
5.00
0,395
0.436
PASS
13
85
113
5.00
|
0.353
|
0.384
|
PASS
14
85
5.00
0.454
PASS
45
85
14.5
5.00
|
0.881
0.881
PASS
16
85
5.00
|
0.790
0.790
PASS
|
17
|
85
10.0
5.00
|
0.556
0.556
PASS
lig
gs
14.7
|
5.00
|
0.886
0.886
PASS
19
85
11.6
5.00
0.651
0.651
PASS
20
95
156
5.00
|
1.100
1.100
|
PASS
Overall Result:
PASS
.
Date:
7/30/2013
ey\
\
Engineering Technician
BFM000116057
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 17 of 60
PageID# 2532
Task Number: TN-19168
Reference No.: CFR 84.181
Test:
Sodium Chloride (NaCI) - N95
STP No.: 59
Manufacturer: Makrite Industries, Inc.
Item Tested: SEKURA-32 I
Comments:
Was all equipment verified to be In calibration throughout all testing?
@ Yea 0 No
Date:
7/30/2013
Signature:
' 11.AAMM \
Engineering Technician
Task Number:
TN-19168
Reference No: CFR 84.181
Test:
Sodium Chloride (NaCl)
- N95
SFP No.: 59
Manufacturer: Makrite Industries, Inc.
Item Tested:
SEKURA-321
Comments:
Was all equipment verified to be in calibration throughout all testing?
@
Yes
(©
No
.
Date:
7/30/2013
\Adame
Engineering Technician
BFM000116058
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 18 of 60
PageID# 2533
BIM:10011Ln
CONFEENTIAL
BFM000116059
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 19 of 60
PageID# 2534
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Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 20 of 60
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CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 21 of 60
PageID# 2536
Wondfo®
SANS-Coll-2 Antibody Test
[Lateral Flow Method]
cool NozW1C5
INTENDED USE
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an
immunochromatographic assay for rapid, qualitative detection of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
IgG/IgM antibody in human whole blood, serum or plasma sample.
The test is to be used as an aid in the diagnosis of coronavirus
infection disease (COVID-19), which is caused by SARS-CoV-2.
The test provides preliminary test results. Negative results don't
preclude SARS-CoV-2 infection and they cannot be used as the sole
basis for treatment or other management decision.
For in vitro diagnostic use only. For professional use only.
SUMMARY
On December 31, 2019, several cases of pneumonia in Wuhan City,
Hubei Province of China were reported to the World Health
Organization (WHO). The novel virus, now known as SARS-CoV-2
(previously known as 2019-nCoV), a RNA virus of the beta
coronavirus family, has since spread across China and to other
countries and territories. The WHO has named the disease caused by
SARS-CoV-2 as coronavirus disease 2019 (abbreviated
"COVID-19").
PRINCIPLE
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is based
on the principle of capture immunoassay for determination of
SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum and
plasma. When the specimen is added into the test device, the
specimen is absorbed into the device by capillary action, mixes with
the SARS-CoV-2 antigen-dye conjugate and flows across the
pre-coated membrane.
When the SARS-CoV-2 antibodies level in the specimen is at or
above the target cutoff (the detection limit of the test), the antibodies
bound to the antigen-dye conjugate are captured by anti-human IgG
antibody and anti-human p chain antibody immobilized in the Test
Region (T) of the device, and this produces a colored test band that
indicates a positive result. When the SARS-CoV-2 antibody level in
the specimen is zero or below the target cutoff, there is not a visible
colored band in the Test Region (T) of the device. This indicates a
negative result.
To serve as a procedure control, a colored line will appear at the
Control Region (C), if the test has been performed properly.
PRECAUTION
1. This kit is for in vitro diagnostic use only.
2. All specimens should be treated as capable of transmitting
diseases. Use appropriate precautions in the collection, handling,
storage and disposal of patient samples and used kit contents. And
follow biosafety level 2 or higher guidelines.
3. Wear appropriate personal protective equipment (e.g. gowns,
gloves, eye protection) when handing the contents of this kit.
4. Proper specimen collection storage and transport are critical to the
performance of this test.
5. Discard after first use. The test cannot be used more than once.
6. Do not touch the reaction area of test strip.
7. Do not use test kit beyond the expiration date.
8. Do not use the kit if the pouch is punctured or not well sealed.
9. Testing should be applied by professionally trained staff working in
certified laboratories or clinics at which the sample(s) is taken by
qualified medical personnel.
10. The test result should be interpreted by the physician along with
clinical findings and other laboratory test results.
11. DISPOSAL OF THE DIAGNOSTIC: All specimens and the
used-kit has the infectious risk. The process of disposing the
diagnostic must follow the local infectious disposal law or
laboratory regulation.
MATERIAL
Material Provided
1. 20 Individual sealed pouches, each pouch contains:
I 1 x Test cassette
I 1 x Desiccant pouch
2. 20 disposable droppers
3. Detection buffer (1*6 mL)
4. Instructions for use
Material Required but Not Provided
1. Specimen Collection Containers
2. Centrifuge (for serum/plasma sample)
3. Timer
4. Personal protective equipment, such a protective gloves, medical
mask, goggles and lab coat.
5. Appropriate biohazard waste container and disinfectants.
STORAGE AND STABILITY
1. Store at 2-30°C in the sealed pouch up to the expiration date
printed on the package. Do not freeze.
2. The test cassette should be used within 1 hour after taking out from
the foil envelope. Buffer solution should be re-capped in time after
use.
3. Keep away from sunlight, moisture and heat.
4. Kit contents are stable until the expiration date printed on the outer
box.
SPECIMEN COLLECTION AND PREPARATION
The test can be performed with whole blood, serum and plasma.
For whole blood:
1. Using standard phlebotomy procedure, collect a venipuncture
whole blood specimen using a blood collection tube with suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give
incorrect result.
2. It is recommended that whole blood specimen is tested at the time
of specimen collection. If the specimens are not tested
immediately, they may be stored at 2°C-8°C for up to 7 days.
Prior to testing, mix the blood by gentle inversion several times, do
not freeze or heat whole blood specimens.
For Serum and Plasma:
1. Using standard phlebotomy procedure, collect a venipuncture
whole blood specimen using a blood collection tube. If collecting
plasma use a blood collection tube containing suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give
incorrect result.
2. Centrifuge whole blood and separate the plasma from red blood
cell as soon as possible to avoid hemolysis.
3. Test should be performed within 8 houres after the specimens have
been collected. Do not leave the specimens at room temperature
for prolonged periods. Serum or plasma specimens may be stored
at 2°C-8°C for up to 3 days prior to testing. Serum or plasma
specimens may be stored at -20°C for up to 9 days.
Note: Bring specimens to room temperature before testing. Frozen specimens
must be completely thawed and mixed well prior to testing. Specimens should
not be frozen and thawed repeatedly. Severe hemolytic or heat-inactivated
specimens are not recommended.
TEST PROCEDURE
Please read the instruction for use carefully before performing the
test.
1. Allow the device, buffer and specimen to equilibrate to room
temperature (10°C -30°C) prior to testing.
2. Remove a test cassette from the foil pouch by tearing at the notch
and place it on a level surface.
3. Transfer 10 pL of whole blood or serum or plasma specimen to the
sample well (small well) and then add 2-3 drops (80 pL) of buffer
solution to the buffer well (large well).
4. As the test begins to work, you will see purple color move across
the result window in the center of the test device.
5. Wait for 15 minutes and read the results. Do not read results after
20 minutes.
Note: the rightmost window on the cassette shows the product abbreviation
nCoV" to identify this product.
RESULT INTERPRETATION
Positive Result
Colored bands appear at both test line (T) and control line (C). It
indicates a positive result for the SARS-CoV-2 antibodies in the
specimen.
Negative Result
Colored band appear at control line (C) only. It indicates that the
concentration of the SARS-CoV-2 antibodies is zero or below the
10pL
•
CpC_) 00240
CONFIDENTIAL
BFM000116062
INTENDED USE
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an
immunochromatographic assay for rapid, qualitative detection of
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
IgG/IgM antibody in human whole blood, serum or plasma sample.
The test is to be used as an aid in the diagnosis of coronavirus
infection disease (COVID-19), which is caused by SARS-CoV-2.
The test provides preliminary test results. Negative results don’t
preclude SARS-CoV-2 infection and they cannot be used as the sole
basis for treatment or other management decision.
For in vitro diagnostic use only. For professional use only.
SUMMARY
On December 31, 2019, several cases of pneumonia in Wuhan City,
Hubei Province of China were reported to the World Health
Organization (WHO). The novel virus, now known as SARS-CoV-2
(previously known as 2019-nCoV), a RNA virus of the beta
coronavirus family, has since spread across China and to other
countries and territories. The WHO has named the disease caused by
SARS-CoV-2
as
coronavirus
disease
2019
(abbreviated
“COVID-19”).
PRINCIPLE
Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is based
on the principle of capture immunoassay for determination of
SARS-CoV-2 IgG/IgM antibodies in human whole blood, serum and
plasma. When the specimen is added into the test device, the
specimen is absorbed into the device by capillary action, mixes with
the SARS-CoV-2 antigen-dye conjugate and flows across the
pre-coated membrane.
When the SARS-CoV-2 antibodies level in the specimen is at or
above the target cutoff (the detection limit of the test), the antibodies
bound to the antigen-dye conjugate are captured by anti-human IgG
antibody and anti-human μ chain antibody immobilized in the Test
Region (T) of the device, and this produces a colored test band that
indicates a positive result. When the SARS-CoV-2 antibody level in
the specimen is zero or below the target cutoff, there is not a visible
colored band in the Test Region (T) of the device. This indicates a
negative result.
To serve as a procedure control, a colored line will appear at the
Control Region (C), if the test has been performed properly.
PRECAUTION
1. This kit is for in vitro diagnostic use only.
2. All specimens should be treated as capable of transmitting
diseases. Use appropriate precautions in the collection, handling,
storage and disposal of patient samples and used kit contents. And
follow biosafety level 2 or higher guidelines.
3. Wear appropriate personal protective equipment (e.g. gowns,
gloves, eye protection) when handing the contents of this kit.
4. Proper specimen collection storage and transport are critical to the
performance of this test.
5. Discard after first use. The test cannot be used more than once.
6. Do not touch the reaction area of test strip.
7. Do not use test kit beyond the expiration date.
8. Do not use the kit if the pouch is punctured or not well sealed.
9. Testing should be applied by professionally trained staff working in
certified laboratories or clinics at which the sample(s) is taken by
qualified medical personnel.
10. The test result should be interpreted by the physician along with
clinical findings and other laboratory test results.
11. DISPOSAL OF THE DIAGNOSTIC: All specimens and the
used-kit has the infectious risk. The process of disposing the
diagnostic must follow the local infectious disposal law or
laboratory regulation.
MATERIAL
Material Provided
1. 20 Individual sealed pouches, each pouch contains:
■ 1 x Test cassette
■ 1 x Desiccant pouch
2. 20 disposable droppers
3. Detection buffer (1*6 mL)
4. Instructions for use
Material Required but Not Provided
1. Specimen Collection Containers
2. Centrifuge (for serum/plasma sample)
3. Timer
4. Personal protective equipment, such a protective gloves, medical
mask, goggles and lab coat.
5. Appropriate biohazard waste container and disinfectants.
STORAGE AND STABILITY
1. Store at 2~30ºC in the sealed pouch up to the expiration date
printed on the package. Do not freeze.
2. The test cassette should be used within 1 hour after taking out from
the foil envelope. Buffer solution should be re-capped in time after
use.
3. Keep away from sunlight, moisture and heat.
4. Kit contents are stable until the expiration date printed on the outer
box.
SPECIMEN COLLECTION AND PREPARATION
The test can be performed with whole blood, serum and plasma.
For whole blood:
1. Using standard phlebotomy procedure, collect a venipuncture
whole blood specimen using a blood collection tube with suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give
incorrect result.
2. It is recommended that whole blood specimen is tested at the time
of specimen collection. If the specimens are not tested
immediately, they may be stored at 2ºC～8ºC for up to 7 days.
Prior to testing, mix the blood by gentle inversion several times, do
not freeze or heat whole blood specimens.
For Serum and Plasma:
1. Using standard phlebotomy procedure, collect a venipuncture
whole blood specimen using a blood collection tube. If collecting
plasma use a blood collection tube containing suitable
anticoagulant (containing EDTA, Heparin or Citrated sodium).
Other anticoagulants have not been validated and may give
incorrect result.
2. Centrifuge whole blood and separate the plasma from red blood
cell as soon as possible to avoid hemolysis.
3. Test should be performed within 8 houres after the specimens have
been collected. Do not leave the specimens at room temperature
for prolonged periods. Serum or plasma specimens may be stored
at 2ºC～8ºC for up to 3 days prior to testing. Serum or plasma
specimens may be stored at -20ºC for up to 9 days.
Note: Bring specimens to room temperature before testing. Frozen specimens
must be completely thawed and mixed well prior to testing. Specimens should
not be frozen and thawed repeatedly. Severe hemolytic or heat-inactivated
specimens are not recommended.
TEST PROCEDURE
Please read the instruction for use carefully before performing the
test.
1. Allow the device, buffer and specimen to equilibrate to room
temperature (10ºC ～30ºC) prior to testing.
2. Remove a test cassette from the foil pouch by tearing at the notch
and place it on a level surface.
3. Transfer 10 μL of whole blood or serum or plasma specimen to the
sample well (small well) and then add 2-3 drops (80 μL) of buffer
solution to the buffer well (large well).
4. As the test begins to work, you will see purple color move across
the result window in the center of the test device.
5. Wait for 15 minutes and read the results. Do not read results after
20 minutes.
Note: the rightmost window on the cassette shows the product abbreviation
“nCoV” to identify this product.
RESULT INTERPRETATION
Positive Result
Colored bands appear at both test line (T) and control line (C). It
indicates a positive result for the SARS-CoV-2 antibodies in the
specimen.
Negative Result
Colored band appear at control line (C) only. It indicates that the
concentration of the SARS-CoV-2 antibodies is zero or below the
SARS-CoV-2 Antibody Test
(Lateral Flow Method)
Catalog No.: W195
1/2
nCoV nCoV nCo
nCoV nCoV nCo
nCoV nCoV nCo
C
T
SARS-CoV-2
nCoV nCoV nCo
nCoV nCoV nCo
nCoV nCoV nCo
C
T
SARS-CoV-2
10μL
2~3 Drops )
@e{Q)
BFM000116062
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 22 of 60
PageID# 2537
IVD
In Vitro
Diagnostic Use
See Instruction
for Use
2
Expiry Date
Tests per Kit
LOT
Batch Number
Store between
2-30°C
Do not reuse
Manufacturing
Date
Manufacturer
Keep Dry
Keep away from
Sunlight
REF Catalog #
detection limit of the test.
Invalid Result
No visible colored band appear at control line after performing the
test. The directions may not have been followed correctly or the test
may have deteriorated. It is recommended that the specimen be
re-tested.
—1
Positive
Negative
Invalid
Invalid
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in
the control region (C) is considered an internal procedural control. It
confirms sufficient specimen volume, adequate membrane wicking
and correct procedural technique.
Good laboratory practice recommends the use of the control
materials. Users should follow the appropriate federal state, and local
guidelines concerning the frequency of assaying external quality
control materials.
LIMITATIONS OF PROCEDURE
1. This reagent is designed to detect antibodies against SARS-CoV-2
in human whole blood, plasma, serum sample.
2. This reagent is a qualitative assay. It is not designed to determine
the quantitative concentration of SARS-CoV-2 antibodies.
3. The accuracy of the test depends on the sample collection process.
Improper sample collection, improper sample storage, or repeated
freezing and thawing of the sample will affect the test result.
4. The test result of this reagent are for clinical reference only, a
confirmed diagnosis should only be made after all clinical and
laboratory findings have been evaluated.
5. Limited by the method of antibody detection reagents, for negative
test results, it is recommended to use nucleic acid detection or
virus culture identification methods for review and confirmation.
6. Positive test results do not rule out co-infections with other
pathogens. A negative result of this reagent can be caused by:
1) Improper sample collection, improper sample transfer or
handing, the virus titer in the sample is too low;
2) The level of SARS-CoV-2 antibodies is below the detection limit
of the test.
3) Variations in viral genes may cause changes in antibody
determinants.
PERFORMANCE CHARACTERISTICS
A. Sensitivity and Specificity
596 clinical case samples which include 361 confirmed case
samples* and 235 confirmed excluded case samples*, were obtained
for testing, and then compared the test results between Wondfo
SARS-CoV-2 Antibody Test (Lateral Flow Method) and the confirmed
case samples. The results of sensitivity and specificity between the
two method are show below.
Reagents
Clinical cases
Total
Confirmed
case samples
Excluded
case samples
Wondfo SARS-CoV-2
Antibody Test
(Lateral Flow Method)
Positive
312
1
313
Negative
49
234
283
Total
361
235
596
* Confirmed cases were the patients diagnosed according to the
treatment plan.
* Confirmed excluded cares were identified by negative PCR results.
Results analysis:
Sensitivity: 86.43% (95%Cl: 82.41%-89.58%)
Specificity: 99.57% (95%Cl: 97.63%-99.92%)
Total consistent: 91.61% (95%Cl: 89.10%-93.58%)
B. Cross-reactivity
Specimens which tested positive with following various agents from
patients were investigated with Wondfo SARS-CoV-2 Antibody Test
(Lateral Flow Method). The results showed no cross reactivity.
Parainfluenza virus antibody
Influenza A antibody
Influenza B antibody
Chlamydia pneumonia antibody
Mycoplasma pneumoniae antibody
Adenovirus antibody
Respiratory syncytial virus antibody
Hepatitis B surface antibody
Hepatitis C virus antibody
Treponema pallidum antibody
HIV antibody
EB virus antibody
Measles vines antibody
Cytomegalovirus antibody
Enterovirus type 71 antibody
Mumps antibody
Varicella-zoster vines positive sample
C. Interferences
The test result of Wondfo SARS-CoV-2 Antibody Test (Lateral Flow
Method) do not be interfered with the substance at the following
concentration:
Substance
Concentration
Bilirubin
250 umol/L
Hemoglobin
9 g/L
Triglyceride
15 mmol/L
Rheumatoid factors
80 IU/mL
Antinuclear antibody (ANA) titer
1:240
Anti-mitochondrial antibody (AMA)
80 U/mL
Mouse IgG
1000 ug/mL
D. Precision
1. Within run precision was determined by using 10 replicates of three
different specimens containing different concentrations of antibody.
The negative and positive values were correctly identified 100% of
the time.
2. Between run precision was determined by using the three different
specimens containing different concentrations of antibody in 3
different lots of test devices. Again negative and positive results
were correctly identified 100% of the time.
BIBLIOGRAPHY
[1] Na Zhu, Ph.D., Dingyu Zhang, M.D., Wenling Wang, Ph.D., et al.
(2020). A Novel Coronavirus from Patients with Pneumonia in
China, 2019. The New England Journal of Medicine.
[2] Chen Wang, Peter W Horby, Frederick G Hayden, George F Gao.
(2020). A novel coronavirus outbreak of global health concern. The
Lancet, 395(10223), 470-473.
[3] Chaolin Huang, Yeming, et al. (2020). Clinical features of patients
infected with 2019 novel coronavirus in Wuhan, China. The
Lancet, 395(10223), 497-506.
[4] Nanshan Chen, Min Zhou, Xuan Dong, et al. (2020).
Epidemiological and clinical characteristics of 99 cases of 2019
novel coronavirus pneumonia in Wuhan, China: a descriptive
study. The Lancet, 395(10223), 507-513.
[5] World Health Organization: Clinical management of severe acute
respiratory infection when Novel coronavirus (nCoV) infection is
suspected: Interim Guidance. 12 January, 2020.
INDEX OF SYMBOL
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Luogang District, 510663,
Guangzhou, P.R.China
Tel: +86-20-32296083 400-888-5268(Toll Free)
Fax: +86-20-32296063
E-mail: sales@wondfo.com.cn
Website: www.wondfo.com.cn
Rev. Al Rd.: 2020/02/28
O
O
CONFIDENTIAL
BFM000116063
detection limit of the test.
Invalid Result
No visible colored band appear at control line after performing the
test. The directions may not have been followed correctly or the test
may have deteriorated. It is recommended that the specimen be
re-tested.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in
the control region (C) is considered an internal procedural control. It
confirms sufficient specimen volume, adequate membrane wicking
and correct procedural technique.
Good laboratory practice recommends the use of the control
materials. Users should follow the appropriate federal state, and local
guidelines concerning the frequency of assaying external quality
control materials.
LIMITATIONS OF PROCEDURE
1. This reagent is designed to detect antibodies against SARS-CoV-2
in human whole blood, plasma, serum sample.
2. This reagent is a qualitative assay. It is not designed to determine
the quantitative concentration of SARS-CoV-2 antibodies.
3. The accuracy of the test depends on the sample collection process.
Improper sample collection, improper sample storage, or repeated
freezing and thawing of the sample will affect the test result.
4. The test result of this reagent are for clinical reference only, a
confirmed diagnosis should only be made after all clinical and
laboratory findings have been evaluated.
5. Limited by the method of antibody detection reagents, for negative
test results, it is recommended to use nucleic acid detection or
virus culture identification methods for review and confirmation.
6. Positive test results do not rule out co-infections with other
pathogens. A negative result of this reagent can be caused by:
1) Improper sample collection, improper sample transfer or
handing, the virus titer in the sample is too low;
2) The level of SARS-CoV-2 antibodies is below the detection limit
of the test.
3) Variations in viral genes may cause changes in antibody
determinants.
PERFORMANCE CHARACTERISTICS
A. Sensitivity and Specificity
596 clinical case samples which include 361 confirmed case
samples* and 235 confirmed excluded case samples*, were obtained
for testing, and then compared the test results between Wondfo
SARS-CoV-2 Antibody Test (Lateral Flow Method) and the confirmed
case samples. The results of sensitivity and specificity between the
two method are show below.
* Confirmed cases were the patients diagnosed according to the
treatment plan.
* Confirmed excluded cares were identified by negative PCR results.
Results analysis：
Sensitivity: 86.43% (95%CI: 82.41%~89.58%)
Specificity: 99.57% (95%CI: 97.63%~99.92%)
Total consistent: 91.61% (95%CI: 89.10%~93.58%)
B. Cross-reactivity
Specimens which tested positive with following various agents from
patients were investigated with Wondfo SARS-CoV-2 Antibody Test
(Lateral Flow Method). The results showed no cross reactivity.
C. Interferences
The test result of Wondfo SARS-CoV-2 Antibody Test (Lateral Flow
Method) do not be interfered with the substance at the following
concentration:
D. Precision
1. Within run precision was determined by using 10 replicates of three
different specimens containing different concentrations of antibody.
The negative and positive values were correctly identified 100% of
the time.
2. Between run precision was determined by using the three different
specimens containing different concentrations of antibody in 3
different lots of test devices. Again negative and positive results
were correctly identified 100% of the time.
BIBLIOGRAPHY
[1] Na Zhu, Ph.D., Dingyu Zhang, M.D., Wenling Wang, Ph.D., et al.
(2020). A Novel Coronavirus from Patients with Pneumonia in
China, 2019. The New England Journal of Medicine.
[2] Chen Wang, Peter W Horby, Frederick G Hayden, George F Gao.
(2020). A novel coronavirus outbreak of global health concern. The
Lancet, 395(10223), 470-473.
[3] Chaolin Huang, Yeming, et al. (2020). Clinical features of patients
infected with 2019 novel coronavirus in Wuhan, China. The
Lancet, 395(10223), 497-506.
[4] Nanshan Chen, Min Zhou, Xuan Dong, et al. (2020).
Epidemiological and clinical characteristics of 99 cases of 2019
novel coronavirus pneumonia in Wuhan, China: a descriptive
study. The Lancet, 395(10223), 507-513.
[5] World Health Organization: Clinical management of severe acute
respiratory infection when Novel coronavirus (nCoV) infection is
suspected: Interim Guidance. 12 January, 2020.
INDEX OF SYMBOL
Rev. A1 Rel.: 2020/02/28
2/2
In Vitro
Diagnostic Use
Tests per Kit
Batch Number
See Instruction
for Use
Manufacturing
Date
Expiry Date
Keep Dry
Keep away from
Sunlight
Do not reuse
Catalog #
Store between
2～30ºC
2
Reagents
Clinical cases
Confirmed
case samples
312
49
361
Total
313
283
596
Excluded
case samples
1
234
235
Total
Wondfo SARS-CoV-2
Antibody Test
(Lateral Flow Method)
Positive
Negative
Parainfluenza virus antibody
Influenza A antibody
Influenza B antibody
Chlamydia pneumonia antibody
Mycoplasma pneumoniae antibody
Adenovirus antibody
Respiratory syncytial virus antibody
Hepatitis B surface antibody
Hepatitis C virus antibody
Treponema pallidum antibody
HIV antibody
EB virus antibody
Measles virus antibody
Cytomegalovirus antibody
Enterovirus type 71 antibody
Mumps antibody
Varicella-zoster virus positive sample
Substance
Bilirubin
Hemoglobin
Triglyceride
Rheumatoid factors
Antinuclear antibody (ANA) titer
Anti-mitochondrial antibody (AMA)
Mouse IgG
Concentration
250 μmol/L
9 g/L
15 mmol/L
80 IU/mL
1:240
80 U/mL
1000 μg/mL
Guangzhou Wondfo Biotech Co., Ltd.
No.8 Lizhishan Road, Science City, Luogang District, 510663,
Guangzhou, P.R.China
Tel: +86-20-32296083 400-888-5268(Toll Free)
Fax: +86-20-32296063
E-mail: sales@wondfo.com.cn
Website: www.wondfo.com.cn
Manufacturer
if ™
™
°
4
4
4
4
Positive
Negative
Invalid
Invalid
0
aye
BFM000116063
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 23 of 60
PageID# 2538
CONFIDENTIAL
BFM000116064
iL
iid ere
BFM000116064
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 24 of 60
PageID# 2539
C E 0194
EN149: 2001+A1:2009
CELI4041333K ( A total of 133 CE approvals )
FFP1NR DTC3W, DTC3W-F, DTC3W-0, DTC3W-OF, DTC3M, DTC3M-F, DTC3M --1. DTC3M-1F,
(49tYPes) DTC3C (dolomite), DTC3C-F(dolomite). DTC3A, DTC3A-F, DTC3A-2F, DTCA1, DTCA1-F,
DTC3R, DTC3R-F, DTC3B(dolomite), DTC3B-F(dolomite). DTC3X(dolomite), DTC3X-F(dolomite),
DTC2XS. DTC2XS-F, DTC3XS, DTC3XS-F, DTC3Z(dolomite), DTC3Z-F(dolomite), DAC4,
DAC4-F, DAC4M, DAC4M-F, DAC4-0, DAC4-0F, DAC4C(dolomite),
DAC4C-F(dolornite),
DAC4M-1, DAC4M-1F, DACA1, DACA1-F, DAC4B(dolomite), DAC4B-F(dolomite),
DAC4X(dolomite), DAC4X-F(dolornite), DAC3XS, DAC3XS-F, DAC4XS, DAC4XS-F.
DAC4Z(dolomite), DAC4Z--F(dolomite)
DTC3W, DTC3W-F, DTC3W-0, DTC3W-OF, DTC3M, DTC3M-F, DTC3M-1, DTC3M-1F,
DTC3C (dolomite), DTC3C-F(dolomite), DTC3A, DTC3A-F, DTC3A-2F. DTCA1, DTCA1-F,
DTC3R, DTC3R-F, DTC3B(dolomite), DTC3B-F(dolomite), DTC3X(dolomite), DTC3X-F(dolomite)•
DTC3Z(dolomite), DTC3Z-F(dolomite), DAC4, DAC4-F, DAC4M, DAC4M-F, DAC4-0, DAC4-0F,
DAC4C(dolomite), DAC4C-F(dolomite), DAC4M-1, DAC4M-1F, DACA1, DACA1-F,
DAC4B(dolomite), DAC4B-F(dolomite), DAC4X(dolomite). DAC4X-F(dolomite), DAC4Z(dolornite)•
DAC4Z-F(do)omite)
DTC3W, DTC3W-F, DTC3W-0. DTC3W-OF, DTC3M, DTC3M-F, DTC3M-1, DTC3M-1F,
DTC3C(dolomite), DTC3C-F(dolomite), DTC3A, DTC3A-F, DTC3A-2F. DTCAI. DTCA1-F,
DTC3R, DTC3R-F, DTC3B(dolomite). DTC3B-F(dolomite), DTC3XD(dolornite),
DTC3XD-F(do)omite), DTC3Z(dolomite), DTC3Z-F(do)omite), DAC4, DAC4-F, DAC4M. DAC4M-F,
DAC4-0, DAC4-0F, DAC4C(dolomite), DAC4C-F(dolomite), DAC4M-1, DAC4M-1F. DACA1,
DACA1-F, DAC4B(dolomite), DAC4B-F(dolornite), DAC4XD(dolomite), DAC4XD-F(dolomite),
DAC4Z(dolomite), DAC4Z-F(dolomite)
DS 8810 (Grade F), DS 8830 (Grade B)
FFP2 NR
(41 types)
FFP3 NR
(41 types)
GOGGLE
(2 types)
AS/NZS1716: 2003
Mic*113EiE4545231C (A total of 52 AS/NZS approvals)
P1
DAC4, DAC4-F, DTC3B, DTC3B-F, DAC4B, DAC4B-F, DTC3M, DTC3M-F, DAC4M, DAC4M-F,
(26 types) DTC3X. DTC3X-F, DAC4X, DAC4X-F, DTCA1, DTCA1-F, DACA1, DACA1-F, DTCA1N, DTCA1N-F,
DACAIN, DACA1N-F, DTC3Z, DTC3Z-F, DAC4Z, DAC4Z-F
P2
DAC4 DAC4-F, DTC3B, DTC3B-F, DAC4B. DAC4B-F, DTC3M, DTC3M-F, DAC4M. DAC4M-F,
(26 types) DTC3X, DTC3X-F, DAC4X, DAC4X-F, DTCA1, DTCA1-F, DACA1, DACA1-F, DTCA1N,
DTCA1N-F, DACA1N, DACA1N-F, DTC3Z, DTC3Z-F, DAC4Z, DAC4Z-F
1-_:imm[Li-lika
chosheng Dasheng Mask Approved Schedule
it
la 230 it(
Total 230 approvals
FDAU4S433K (A total of 3 FDA approvals)
3-ply facemask in white/ bule/ yellow( pink/ green, DTC3B N95, DTC3M-1 N95
M(T 30)q
3) TM556~
DRIA DS2
E. Japan Approved
El*DS2i.143#83K (A total of 8 DS2 approvals)
FDA
NIOSH NIOSH
Es NIOSH
N95
N99
CIIN991.114.4431( (A total of 4 NIOSH N99 approvals)
N95
DTC3W, DTC3W-F, DTC3W-0, DTC3W-OF, DTC3M-1, DTC3C-F, DTC3A, DTC3A-F, DTC3A-2F.
(3o types) DTCA1, DTCA1-F, DTCA1N, DTCA1N-F. DTC3B, DTC3B-F, DTC3X, DTC3X-F, DAC4, DAC4-F.
DAC4C, DAC4C-F, DAC4A, DACA1, DACA1-F, DAC4X, DAC4X-F, DAC4B, DAC4B-F, DTC3Z,
DTC3Z-F
r
>;if
.s•C
1=1N95iiTIS14303tk (A total of 30 NIOSH N95 approvals)
DTCA1, DTCA1-F, DTCA1N, DTCA1N-F
N99
(4 types)
CONFIDENTIAL
BFM000116065
BFM000116065
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 25 of 60
PageID# 2540
NIOSH-N95/FDA (R)f N95 ri A) DTC3B N95
• • • •
•
111
1111
\
V. ;
f;Pa.64.0,11
1.710SH
Respirator Mask
fA Val 1:,gAMWAllof fig.g4
DTC3B
CONFIDENTIAL
BFM000116066
NIOSH-N95/FDA（医用N95 口罩）DTC3B N95
—
Pe
_
ane
=
.
ESS
ha
sae
Se
sSiaim”
orceses
BFM000116066
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 26 of 60
PageID# 2541
tits_ Maggie Thong
Shanghai Dastseng Health Products Manufacture Co., Ltd.
Room 604. No. 7 Building
No.20 Handan Road
Shanghai, 200437
CHINA
Dear Ms. Zhong:
The National Institute for Occupational Safety and Health (NIOSH) has reviewed your request
dated May 5. 2006. 'This request was for an approval of the model DTC3B N95 filtering
facepiece respirator.
This request is granted. Approvals are granted only for documentation written in the English
language. It is the manufacturer's responsibility to correctly translate materials desired in
languages other than English. Approval number TC-84A-4336 has been assigned. The
respirator is approved for protection at an N95 particulate efficiency level.
The diskette enclosed with this letter contains the final respirator approval label. The abbreviated
label has been accepted as submitted. The cautions and limitations, which apply to this approval,
arc on the approval label. Only those assemblies affected by this request, or where new approval
numbers are assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
The approved assembly consists of the parts as listed on the approval labels plus the assembly
matrices. Parts are to be marked with the numbers indicated on the approval label in a legible
and pemtanent manner (marking cannot be removed without evidence of its previous presence).
This certificate of approval is not an endorsement of the respirator by NIOSH, and such
endorsement shall not be stated or implied in advertisements or other publicity. However, you
may publicize the fact that this respinftor has met the requirements of Title 42, Code of Federal
Regulations. Part 84.
NIOSH-N95
FDA
5101(0910131
•
CONFIDENTIAL
BFM000116067
NIOSH-N95 认证，FDA 注册号：510K0910131
BFM000116067
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 27 of 60
PageID# 2542
95 Respirator Mask
rikAirtitMatorgiiisfigcg
ST-31.11WWitffW
DTC3W
NTOSH—N95 (N95 I:/ *) DTC3W N95
CONFIDENTIAL
BFM000116068
NIOSH-N95（N95 口罩）DTC3W N95
BFM000116068
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 28 of 60
PageID# 2543
r
Ma Maggie Thong
Shanghai Dasheng Health Products Manufacture Co... Ltd. i
Room 604, No. 7 Building
No.20 Handan Road
Shanghai. 200437
CHINA
Dear Ms. Zhong:
The National Institute for Occupational Safety and Health (NIOSI I) has reviewed your request
dated May 5. 2006. This request was for an approval of the model number DTC3W N95
filtering facepiece respirator.
This request is granted. Approvals arc granted only for documentation written in the English
language. It is the manufacturer's responsibility to correctly translate materials desired in
languages other than English. Approval number TC-84A-4335 has been assigned. The
respirator is approval for protection at an N95 particulate efficiency level.
11111
The approved assembly consists of the parts as listed on the approval labels plus the assembly
The diskette enclosed with this letter contains the final respirator approval label. The abbreviated
label has been accepted as submitted. The cautions and limitations which apply to this approval
arc on the approval label. Only those assemblies affected by this request, or where new approval
numbers are assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
matrices. Parts are to be marked with the numbers indicated on the approval label in a legible
and permanent manner (marking cannot be removed without evidence of its previous presence).
This certificate of approval is not an endorsement of the respirator by NIOSII, and such
endorsement shall not be stated or implied in advertisements or other publicity. However, you
may publicize the fact that this respirator has met the requirements of Title 42, Code of Federal
Regulations, Part 84.
4!
Mil
NIOSH-N95 AIE
CONFIDENTIAL
BFM000116069
NIOSH-N95 认证
BFM000116069
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 29 of 60
PageID# 2544
I
gadAelisr
Respirator Mask
Pai.Ltkr,5t PhfOivt'oPTPRRI
DTC3X
r6Shargre Daterrq
rA- Prat Products_
Mask pay owsx.
SLOSH N95
?'o/Tcuthld Resdwator
20 pack
ZMNIOSH N95#;
NIOSH—N95 (N95 OA) DTC3X N95
CONFIDENTIAL
BFM00011 6070
NIOSH-N95（N95 口罩）DTC3X N95
BFM000116070
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 30 of 60
PageID# 2545
Public Health Service
Cantors for Disease Control
and Prevention (CDC)
National institute for Occupational
Safety and Hearth (NIOSH)
National Personal Protective
'Technology Laboratory (NPPTL)
P.O. Box 18010
Pittsburgh, PA 15230-0070
Phone. 412-386-4000
Fax'
412-3135-4051
July 20. 2006
NI s\ 'lift If
11-2
Ms. Maggie Zhong
Shanghai Dasheng Health Products Manufacture Co.. Ltd.
Room 604, No. 7 Building
No.20 Handan Road
Shanghai. 200437
CHINA
Dear Ms. Zhong:
The National Institute for Occupational Safety and Health (NIOSH) has reviewed your request
dated May 15. 2006. This request was for approval of the model DTC3X N95 filtering facepiece
air purifying respirator. In addition, the request included the presentation of the Shanghai
Dashenst Health Products Manufacture Co. Quality Manual, Edition B. dated May 10, 2003.
This request is granted. Approvals are granted only for documentation written in the English
language. It is the manufacturer's responsibility to correctly translate materials desired in
languages other than English. Approval number TC-84A-4329 has been assigned. The
respirator is approved for protection at a N95 particulate efficiency level.
NIOSH has also reviewed the quality manual presented and finds that it meets or exceeds the
minimum technical requirements for quality assurance plans outlined in Title 42. Code of
Federal Regulations (CFR), Part 84.41(a) and on the bases of this review an approval is granted
for this quality manual.
The CD enclosed with this letter contains the final respirator approval label. The abbreviated
label has been accepted as submitted. The cautions and limitations, which apply to this approval,
are on the approval label. Only those assemblies affected by this request, or where new approval
numbers arc assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
The approved assembly consists of the parts as listed on the approval label and the assembly
matrix. Parts are to be marked ‘t ith the numbers indicated on the approval label in a legible and
permanent manner (marking cannot be removed without evidence of its previous presence).
NIOSH-N95
-1,E
CONFIDENTIAL
BFM000116071
NIOSH-N95 认证
BFM000116071
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 31 of 60
PageID# 2546
Respirator Mask
AMT.W.V0IPAN
NIOSH-N95 (N95 p*) DTC3Z N95
CONFIDENTIAL
BFM000116072
NIOSH-N95（N95 口罩）DTC3Z N95
20 rey-Teds
os=1g
caanaaile
BFM000116072
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 32 of 60
PageID# 2547
Centers kr
Cara.
endPower*Ion (90C)
Nesionel Melba
. it for Illecupalanal
Safety and Health (NOSH)
Nellond Personal Probate.
Technology Laboratory (NPPTL)
626 Cochrane WI Road
PIttablogh. PA 15236-0010
Phone. 412-386-4000
Pea
412486-4051
July 29, 2019
MAR SIVRVIC28
Ms. Jenny Wu
Vice GM
Shanghai Dasheng Health Products Manufacture Co., Ltd.
No. 228 Shihui Rd, Songjiang
Shanghai 201613
CHINA
Dear Ms. Wu:
The National institute for Occupational Safety and Health (N1OSH) has reviewed your request
accepted May 22, 2019. This request was for approval of the model DTC3Z N95 air-purifying
filtering facepiece respirator for protections against particulates at a N95 filter efficiency level.
The complete respirator configuration is detailed on the assembly matrix, file name DTC3Z N95
Atia.x/s, revision a, dated: 05-09-2019.
This request is granted. Approvals are granted only for documentation written in the English
language. It is the manufacturer's responsibility to correctly translate materials desired to be
produced in languages other than English. Approval number TC-84A-8150 has been assigned.
This respirator is approved for protection against particulates at a N95 filter efficiency level.
The final respirator label is included as attachments to this letter. The abbreviated label has been
accepted as submitted. The cautions and limitations which apply to this approval are on the
approval label. Only those assemblies affected by this request, or where new approval numbers
are assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
The approved assembly consists of the parts as listed on the approval label and the assembly
matrix. Parts are to be marked with the numbers indicated on the approval label in a legible and
permanent manner (marking cannot be removed without evidence of its previous presence).
This certificate ofapproval is not an endorsement of the respirator by NIOSH, and such
endorsement shall not be stated or implied in advertisements or other publicity. However, you
may publicize the fact that this respirator has met the requirements of Title 42, Code of Federal
Regulations, Part 84 (42 CFR 84).
NTOSH-N95 IE
CONFIDENTIAL
BFM000116073
NIOSH-N95 认证
BFM000116073
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 33 of 60
PageID# 2548
NIOSH-N95 (N95 I:I _IV-)
CI
CONFIDENTIAL
BFM00011 6074
NIOSH-N95（N95 口罩）带阀门
REDLINE
BFM000116074
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 34 of 60
PageID# 2549
Respirador N95 descartable
para particular con carbon activo y
Valvula de exhalacion
NIOSH—N95 (N95 ri*) 01f-14V-fit
CONFIDENTIAL
BFM000116075
NIOSH-N95（N95 口罩）带阀门碳纤维
BFM000116075
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 35 of 60
PageID# 2550
FINAL REPORT
BACTERIAL FILTRATION EFFICIENCY
AND DIFFERENTIAL PRESSURE
PROCEDURE NO. STP0004 REV 02
LABORATORY NO 448576
PREPARED FOR
SHANGHAI DASHENG HEALTH PRODUCTS MANUFACTURER CO_, LTD
NO. 228 SHIHUI RD
ZHONGSHAN ST, SONGJIANG DISTRICT
SHANGHAI 201613
P.R. CHINA
SUBMITTED BY
NELSON LABORATORIES. INC
6280 S REDWOOD RD,
SALT LAKE CITY UT 84123-6600
801-290-7500
Page 1 of 8
BFM000116076
CONFIDENTIAL
BFM000116076
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 36 of 60
PageID# 2551
NELSON
I
\ It t
Al,/ h I II ti
BACTERIAL FILTRATION EFFICIENCY
AND DIFFERENTIAL PRESSURE
LABORATORY NUMBER:
448576
PROCEDURE NUMBER:
STP0004 REV 02
SAMPLE SOURCE
Shanghai Dasheng Health Products
Manufacturer Co-, Ltd
SAMPLE IDENTIFICATION:
Refer to Tables 1-3
DEVIATIONS:
None
SAMPLE RECEIVED DATE:
27 Oct 2008
LAB PHASE START DATE:
03 Nov 2008
LAB PHASE COMPLETION DATE:
10 Dec 2008
REPORT ISSUE DATE
11 Dec 2008
INTRODUCTION.
This test procedure was performed to determine the bacterial filtration efficiency (BFE) of
various filtration materials, employing a ratio of the bacterial challenge counts to sample effluent
counts, to determine percent bacterial filtration efficiency (%BFE). This procedure provides a
more severe challenge to most filtration materials than would be expected in normal use. This
test procedure allowed a reproducible bacterial challenge to be delivered to test matenals. This
method complies with ASTM F2101
The differential pressure (LP or Delta P) test determined the air exchange differential of the
porous materials. The technique involved a simple application of a basic physical principle
employing a water manometer differential upstream and downstream of the test material, at a
constant flow rate. A digital manometer may be used in place of a water manometer.
ACCEPTANCE CRITERIA.
The BFE control average must be 2200 ± 500 colony forming units (Cal) A BFE run with a
control average of less than 1700 shall be unacceptable. Challenges greater than 2700. but
less than 3000, are, in our expenence, valid. Acceptance of runs with control averages
exceeding 2700 shall be at the sponsor's approval
The mean particle size (MPS) of the challenge aerosol must be maintained at 3.0 ± 0.3 pm
The average % BFE for the reference material must be within the upper and lower control limits
established for the BFE test
The average Delta P result for the reference material must be within the upper and lower control
limits established for the Delta P test.
Page 2 of 8
r
BFM00011 6077
&nurinFhITIAL
BFM000116077
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 37 of 60
PageID# 2552
NELSON
Shanghai Dasheng Health Products Manufacturer Co Ltd
Bacterial Filtration Efficiency
Lab Number 448576
and Differential Pressure,
SAMPLE PREPARATION:
BFE test samples were conditioned for a minimum of 4 hours at 21 t 5'C and 85 t 5% relative
humidity pnor to testing.
TEST PROCEDURE:
A culture of Staphylococcus aureus. ATCC #6538, was diluted in 1.5% peptone water (PEPW)
to a precise concentration to yield challenge level counts of 2200 t 500 CFU per test sample.
The bacterial culture suspension was pumped through a 'Chicago' nebulizer at a controlled flow
rate and fixed air pressure. The constant challenge delivery, at a fixed air pressure, formed
aerosol droplets with a MPS of approximately 10 pm. The aerosol droplets were generated in a
glass aerosol chamber and drawn through a six-stage, viable particle, Andersen sampler for
collection. The collection flow rate through the test sample and Andersen sampler was
maintained at 28.3 Liters per minute (Lpm) (1 cubic foot per minute (CFM)). Test samples,
positive controls and reference material received a one minute challenge followed by a one
minute vacuum cycle.
The delivery rate of the challenge also produced a consistent challenge level of 2200 ± 500
CFU on the test control plates. A test control (no filter medium in the airstream) and reference
matenal are included after 5-11 test samples. The Andersen sampler, a sieve sampler,
impinged the aerosol droplets onto six soybean casein digest agar (SCDA) plates based on the
size of each droplet. The agar plates were incubated at 37 t 2°C for 48 t 4 hours and the
colonies formed by each bacteria laden aerosol droplet were counted and converted to probable
hit values using the hole conversion chart provided by Andersen. These converted counts were
used to determine the average challenge level delivered to the test samples. The distribution
ratio of colonies for each of the six agar plates were used to calculate the MPS of the challenge
aerosol.
'he ,5P test simply measured the differential air pressure on either side of the test sample using
n incline, "U" tube, or digital manometer. Testing was conducted at a how rate of 8 Lpm
,olumetric).
SULTS:
P results are summarized in Tables 1-3.
CONFIDENTIAL
BFM000116078
BFM000116078
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 38 of 60
PageID# 2553
Page 5 of 8
NEL)ON
shanghai Dasheng Health Products Manufacturer Co Ltd
Bacterial Filtration Efficiency
Lab Number 448576
and Differential Pressure
TABLE "I Results
Sample Identification: DS Cuped Surgical Mask
UNIT NUMBER
1
2
3
4
5
DP
(rnm H70/cm')
7.2
6.3
6.2
6.8
6.2
PERCENT
BFE
>99.9%
>99.9%a
>99.9%'
>99.9%
>99,9%
CONTROL AVERAGE: 2347 CFU
MEAN PARTICLE SIZE: 2.8 pm
4 There were no detected colonies on any of the Andersen sampler plates for this sample.
_ I
J
CONFIDENTIAL
BFM000116079
BFM000116079
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 39 of 60
PageID# 2554
P
N
NELSON
Oka.:ems
Miemstiectunerr Ca t.14
Oriebrer
tab Number 448576
TABLE 2 Results
Sample leereAcat,on DS Fotderl SutWcal Mask
UNIT NUMBER
AP
.
(mm ti20/cmi
PERCENT
BFE
1
7.2
>99.9%'
2
7.3
>99.9%•
3
7.1
,99.9%*
4
7.1
>99.9%'
5
6.9
>99.9%s
CONTROL AVERAGE: 2347 CFU
MEAN PARTICLE SIZE: 2 8 pm
There were no detected colonies on any of the Andersen sampler plates for this sample.
Page 6 of 8
CONFIDENTIAL
BFM000116080
BFM000116080
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 40 of 60
PageID# 2555
Bacterial Filtration Efficiency
and Differential Pressure
Z48
oa,tieng Health Products Manufacturer Ce.. Ltd
r 44
576
NELICON
N t R
TABLE 3. Results
Sample I
dentification. DS Flat Surgical Masks
UNIT NUMBER
AP
mm H20/cm'
2.7
2
2.8
3
3.1
4
27
5
2,9
CONTROL AVERAGE: 2347 CFU
MEAN PARTICLE SIZE: 2.8 pm
a There were no detected colonies on any of the Andersen sampler plates for this sample.
PERCENT
BFE
>99,9%
>99.9V
>99.9%4
>99.9%4
>99:9%4
Page 7 of 8
CONFIDENTIAL
BFM000116081
BFM000116081
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 41 of 60
PageID# 2556
NELSON
ft,.
I
f ‘•
Shanghai Dasheng Health Products Manufacturer Co.. Ltd
Lab Number 448576
Bacterial Filtration Efficiency
and Differential Pressure
All reports and letters issued by Nelson Laboratories. Inc. are for the exclusive use of the
sponsor to whom they are addressed. These results relate only to the samples tested. Reports
may not be reproduced except in their entirety. No quotations from reports or use of the
corporate name is permitted except as expressly authorized by Nelson Laboratories, Inc. in
writing. The significance of any data is subject to the adequacy and representative character of
the samples tendered for testing. Nelson Laboratories, Inc warrants that all tests are performed
in accordance with established laboratory procedures and standards. Nelson Laboratories. Inc.
makes no other warranties of any kind, express or implied. Nelson Laboratories, Inc. expressly
states that it makes no representation or warranty regarding the adequacy of the samples
tendered for testing for any specific use of application, that determination being the sole
responsibility of the sponsor. Nelson Laboratories' liability for any loss or damage resulting from
its actions or failure to act shall not exceed the cost of tests performed, and it shall not be liable
for any incidental or consequential damages.
Page 8 of 8
CONFIDENTIAL
BFM0001160132
BFM000116082
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 42 of 60
PageID# 2557
CONFEZEITAL
1/F110(01•10.3
Vondfo
Leading POCT Manufacturer
PAUTe
(Yondfo"
| Ummunechromatopraphy
Assay)
Pa
One Step
COVID-19
Test
is
used for detecting COVID-19
antibodies in human whole blood, serum of plasma sample, and
is suitable for the preliminary screening test for the patients with
suspected COVID-19 infection,
Forin vitro diagnostic use only.
PRINGLE
One Step COVID-19 Test uses with Immunochromatography
assay for the detection of COVID-19 antibodies in human whole
blood. serum and plasma. When the COVID-19 antibody fevel in
the specimen is al or above the target cutoff (the detection limitof
the test), the antibody bound fo the antigen-dye conjugate are
captured by anti-COVID-19 antibody immobilized in the Test
Region
of the device, and this produces a colored testband
that indicates a positive result, When the COVID-19 antibody
lavel.in thecoacimen.ic
arnat
cite
feaCie
arees
elthie(tata
met tay
Sala
COVID-19
One Step COVID-19 Test (ImmunochromatographyAssay)
Sen pet
Ses
iealitin
TMLee
@
BFM000116083
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 43 of 60
PageID# 2558
NATIVE DOCUMENT PLACEHOLDER
Please review the native document BFM000116084.mp4
CONFIDENTIAL
BFM000116084
NATIVE DOCUMENT PLACEHOLDER
Please review the native document BFM000116084.mp4
BFM000116084
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 44 of 60
PageID# 2559
II SIM11 IOW
©Conforms
toMOSH
©Prewrdes
Fier ot
@iypontergen
Letee
Free
@High Feeeter Capac
©ABps ablepretedmorrow
Ovesee Comm tee
©Dripoeets| Berele Lee
BFM000116085
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 45 of 60
PageID# 2560
• L-288 TC-84A-7228
•N95 cup type mask
•It is suitable for particle protection from
buildings, mines, foundry, electronics,
pharmaceuticals, physics and grinding.
•NIOSH N95 approved
Filtration efficiency --95%
•Package: 20 pcs/box, 20 boxes/carton
40
COOMMOITLOL
IINI000111001
TC-84A-7228
cup type mask
is suitable for particle protection from
buildings, mines, foundry, electronics,
pharmaceuticals, physics and grinding.
NIOSH N95 approved
Filtration efficiency
Package: 20 pcs/box, 20 boxes/carton
BFM000116086
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 46 of 60
PageID# 2561
CONFIDENTIAL
BRE100118087
Ye.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Disease Control
and Prevention (CDC)
National Institute for Occupational
ne
NIOSH Reference: TN-19824
and Health (NIOSH)
Mfr. Reference:
GHCL-188
National
F
soy Laboretony GUPPTL)
Technology
P.O. Box 18070
Pittsburgh, PA 15236-0070
Phone:
412-386-4000
Fax:
412-386-4051
December 15, 2014
Mr. Wanghua Xu
Management Representative
Guangzhou Harley Commodity Company Limited
Floor 1 to 4, #8, Team 17, Sandong Village
Xinhua Street, Huadu District
Guangzhou 510800
CHINA
Dear Mr. Xu:
The National Institute for Occupational Safety and Health (NIOSH) has reviewed your request
accepted September 17, 2014. This request was for approval of the model L-188 N95 filtering
facepiece air purifying respirator for protections against particulates at a
filter efficiency
level, reference assembly matrix L-188 Ama.xls, In addition, the Guangzhou Harley Commodity
Company QA Manual, version Al, effective date 2014-06-10, was submitted for review.
This request is granted. Approvals are granted for English language only on all documentation.
It is the manufacturer's responsibility to correctly translate materials desired in languages other
than English. Approval number TC-84A-6973 has been assigned. This respirator is approved
for protection against particulates at a N95 filter efficiency level.
NIOSH has also reviewed the quality manual presented and finds that this manual meets or
exceeds the minimum technical requirements for quality assurance plans as outlined in Title 42,
Code ofFederal Regulations (CFR), Part 84.41(a) and, on the basis ofthis review, this quality
manual is accepted.
The CD enclosed with this letter contains the final respirator label. The abbreviated label is
accepted as submitted. The cautions and limitations which apply to this approval are on the
approval label, Only those assemblies affected by this request, or where new approval numbers
are assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
The approved assembly consists of the parts as listed on the approval label and the assembly
matrix. Parts are to be marked with the numbers indicated on the approval label in a legible and
permanent manner (marking cannot be removed without evidence of its previous presence).
BFM000116087
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 47 of 60
PageID# 2562
CONFIDENTIAL
BF1110001180813
Page 2- Mr. Wanghua Xu
- TN-19824
This certificate ofapproval is not an endorsement ofthe respirator by NIOSH, and such
endorsement shall not be stated or implied in advertisements or other publicity. However, you
may publicize the fact that this respirator has met the requirements ofTitle 42, Code ofFederal
Regulations, Part 84 (42 CFR 84).
No changes may be made to any respirators and accompanying documentation withoutprior
Written approval of NIOSH. Requests for changes must be submitted to NIOSH and a
modification ofthis approval must be granted before changes are made.
A copy of the quality manual will be retained by NIOSH and incorporated into our files. Any
future changes to this accepted quality document must be submitted to NIOSH for a modification
ofthis accepted quality system.
Sincerely yours,
onAV
than V, Szalajda
Acting Chief, Technology Evaluation Branch
National Personal Protective Technology Laboratory
Enclosures
BFM000116088
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 48 of 60
PageID# 2563
CONFIDENTIAL
BFN0001113089
pet
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Disease Control
and Prevention (CDC)
National Institute for Occupational
“nee
NIOSH Reference: TN-19825
Safety and Health (NIOSH)
Mfr. Reference:
GHCL-288
National Personal Protective
TechnologyLaboratory(NPPTL)
P.O. Box 18070
Pittsburgh, PA 15236-0070
Phone:
412-386-4000
Fax:
412-386-4051
December 15, 2014
wMltiny,
Mr. Wanghua Xu
Management Representative
Guangzhou Harley Commodity Company Limited
Floor | to 4, #8, Team 17, Sandong Village
Xinhua Street, Huadu District
Guangzhou 510800
CHINA
Dear Mr, Xu:
The National Institute for Occupational Safety and Health (NIOSH) has reviewed your request
accepted September 17, 2014. This request was for approval of the model L-288 filtering
facepiece air purifying respirator for protections against particulates at a
filter efficiency
level, reference assembly matrix L-288 AMa.xls.
This request is granted. Approvals are granted for English language only on all documentation.
It is the manufacturer’s responsibility to correctly translate materials desired in languages other
than English, Approval number TC-84A-7228 has been assigned. This respirator is approved
for protection against particulates at a N95 filter efficiency level.
The CD enclosed with this letter contains the final respirator approval label. The abbreviated
label has been accepted as submitted. The cautions and limitations which apply to this approval
are on the approval label, Only those assemblies affected by this request, or where new approval
numbers are assigned, apply to this approval action. Production approval labels cannot include
information on unapproved configurations.
The approved assembly consists of the parts as listed on the approval label and the assembly
matrix. Parts are to be marked with the numbers indicated on the approval label in a legible and
permanent manner (marking cannot be removed without evidence of its previous presence).
This certificate ofapproval is not an endorsement of the respirator by NIOSH, and such
endorsement shall not be stated or implied in advertisements or other publicity. However, you
may publicize the fact that this respirator has met the requirements of Title 42, Code ofFederal
Regulations, Part 84 (42 CFR 84).
BFM000116089
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 49 of 60
PageID# 2564
CONFIDENTIAL
BFN0001113090
Page 2- Mr. Wanghua Xu - TN-19825
No changes may be made to any respirators and accompanying documentation without prior
Written approval of NIOSH. Requests for changes must be submitted to NIOSH and a
modification of this approval must be granted before changes are made.
Sincerely yours,
an
Jonathan V. Szalajda
Acting Chief, Technology Evaluation Branch
National Personal Protective Technology Laboratory
Enclosures
BFM000116090
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 50 of 60
PageID# 2565
coluarsinat
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BOGS, IF
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 51 of 60
PageID# 2566
C ON FEENTIM.
BR1ton14:02
BFM000116092
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 52 of 60
PageID# 2567
Shanghai Dasheng Health Products Manufacture Co.,Ltd
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page I of 3
510(k) Summary
APR 2 7 2009
This summary of 510K safety and effectiveness information is being submitted in accrodance
with the requirements of 21 CFR 807.92.
The assigned 510K number is 1<0 ci 01 31
1. Submitter's Identification:
Shanghai Dasheng Health Products Manfuacture Co.,Ltd
No.228 Shihui Road, Zhongshan street, Songjiang District,
Shanghai, P.R.China
Contact
Maggie Zhong
Te1:+86-21-33907930
Fax:+86-21-33907932
Mail:
Date of Summary: Jan 11th, 2009
2. Device Name:
DS N95 Surgical Masks and flat surgical masks
3. Classification Nairte: Surgical N95 Mask and flat surgical mask
4.. Device Description
The IDS DTC3M-1 N95 surgical mask is constructed from a polypropylene
spunbond used in the outer layer. The non-woven PP micro is the filter media and
the Terylene is layered as the inner. The head strap is made of natural rubber(for
double head straps) which is stapled to the mask The inside nosepiece is a soft
sponge foam.
The DS DTC3B N95 surgical mask is constructed from a polypropylene spunbond
used in the outer cover, a polypropylene spunbond used in the inner cover. The
non-woven PP micro fiber and polypropylene melt blown filter media is layered
between the inner and out cover. The head straps are made of woven elastic
strap(for single headband) which is circule to the mask. The inside nosepiece is a
EVA micro-aperture foam.
The flat surgical masks (colors: blue, green, pink, white, yellow, orange) are flat
pleated by 3-ply masks with outer layer and inner layers (spunbonded
polypropylene) that sanwich a meltbown non-woven PP micro fibre filter material;
Ear-loops are made of spandex belt for free elastic -loops. The nose piece for all DS
Face Masks is malleable wire. Fog free masks have an anti-fog strip. Masks with
splash visors have anti-fog treated plastic shield attached to masks,All of the
material used in the construction of the DS Surgical Masks are being used in
currently marketed devices (see predicate information).
All items are no—sterilized and only for single use.
5. Intended Use:
DS N95 surgical masks and flat surgical mask are intended for single use by
operating room personnel or general health care workers for protection against
microscopic organisms, body fluids and particulates. These would indude use
procedure mask, isolation mask or dental face mask.
CONFIDENTIAL
BFM000116093
Shanghai Dasheng Health Products Manufacture Co.,Ltd
No.228 Shilni Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page 1 of 3
510(k) Summary
AR 20
This summary of 510K safety and effectiveness information is being submitted in accrodance
with the requirements of 21 CFR 807.92.
The assigned 510K(number is jO'?O1 I3
1. Submitter's
Identificatioa:
Shanghai Dasheng Health Products Manfuacture Co.,Ltd
No.228 Shihui Road, Zhongshan shreet, Songjiang District,
Shanghai, P.R.China
Contact:
Maggie Zhong
Tel:+86-21-33907930
Fax:+8621-33907932
Mail:
Date of Summnary: Jan 11th, 2009
2. Device Name:
DS6 N95 Surgical Masks and flat surgical masks
3. Classification Maine:
Surgical N95 Mask and flat surgical mask
4..
Device Description
The DS DTC3M.-1 N95 surgical mask is constructed from a polypropylene
spunbond used in the outer layer. The non-woven PP micro is the filter media and
the Terylene is layered as the inner. The head strap is made of natural rubber(for
double head straps) which is stapled to the mask- The inside nosepiece is a soft
sponge foam.
The DS9 DTC3B N95 surgical mask is constructed from a polypropylene spunbond
used in the outer cover, a polypropylene spunbond used in the inner cover. The
non-woven PP micro fiber and polypropylene melt blown filter media is layered
between the inner and out cover. The head straps are made of woven elastic
strap(for single headband) which is circule to the mask. The inside nosepiece is a
EVA midcro-aperture foamt
The flat surgical masks (colors: blue, green, pink, whidte, yellow, orange) are flat
pleated by 3-ply masks withi outer layer and inner layers (spunbonded
polypropylene) that sanwich a meltbown non-woven PP micro fibre filter material;
Ear-loops are made of spandex belt for free elastic 4 oops. The nose piece for all DS
Face Masks is malleable wire. Fog free masks have an anti-fog strip. Masks with
splash visors have anti-fog treated plastic shield attached to maskcs,AII of the
material used in the construction of the DS Surgical Masks are being used in
currently marketed devices (see predicate information).
All items are no -sterilized and only for single use.
5.
Intended Use:
DS N95 surgical masks and flat surgical mask are intended for single use by
operating room personnel or general health care workers for protection against
microscopic organisms, body fluids and particulates. These would include use
procedure mask, isolation mask or dental face mask.
BFM000116093
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 53 of 60
PageID# 2568
Shanghai Dasheng Health Products Manufacture Co.,Ltd KC S 013
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page 2 of 3
6. Comparison to Predicate Devices
DS N95 surgical masks DTC3M-1. DTC3B and flat surgical masks color pink, blue, white,
green, yellow, orange are substantially equivalent is safety and effectiveness to the predicate
device.
Aearo Company- K041855 Pleated plus 1050 and 10505
Gerson Isolair Cornpay -K960778 APR Type N95 model 2735
Tucker & Associates company-K.0777% Surgical face masks white, yellow, pink, blue and green
For reference: FXX, 878 4040. Class II
Manufacturer
Shanghai Dasheng Health Products
Manufacture Co.,Ltd
Aearo Company
Predicate device-for reference
Device
DTC3B N95 Surgical Mask
(New. device)
Pleated plus 1050 and 1050S
510K Number
K041855
Product code
MSH, 878.4040
SAME
Device
Description
1. N95 Class Particuliar respirator
2. Multi-layer filteirng media
(white polypropylene spundbond, Non-woven
PP Micro fiber meltblown, polypropylene,
polypropylene)
3. Plastic nose wire
4. White elastic headband
5. Dimension
153" circumference
6. Flat pleated mask
7. Single elastic head strap
1. N95 Class Particuliar respirator
2. Multi-layer filteirng media
(White
spundbond
polypropylene,
meltblown polypropylene)
3. Tie wire nose piece
4. White elastic headband
5. Dimension
Small (13.5" circumference)
Large(15.5" circumference)
6. Flat pleated mask
7. Dual elastic head strap
N1OSH
certification#
TC-84A-4336
TC-84A-7630
Manufacturer
Shanghai Dasheng Health Products
Manufacture Co.,Ltd
Gerson Isolair APR Company
Predicate device-for reference
Device
DTC3M-1 N95 Surgical Mask
(New device)
N95 model 2735
510K Number
K960778
Product code
MSH, 878.4040
SAME
Device
Description
1. N95 Class Particuliar respirator
2. Multi-layer filteirng media
(white polypropylene, non-woven PP micro
fiber meltblown, Terylene)
3. Plastic nose wire
4. Natural rubber, latex free
5. Dimension
15.75" circumference
6. Molded Cup
7. Dual elastic head strap
1. N95 Class Particuliar respirator
2. Multi-layer filteirng media
(White nonwoven polyester meltblown
polypropylene)
3. Plastic nose wire
4. Yellow elastic, latex free
5. Dimension
Small (13.75" circumference)
6. Molded Cup
7. Dual elastic head strap
NIOSH
certification#
TC-84A-4331
TC-84A-160
2-
CONFIDENTIAL
BFM00011 6094
Shanghai Dasheng Health Products Manufacture Co.,Ltd KUJ 0I1
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page 2 of 3
6. Comparison to Predicate Devices
DS N95 surgical masks DTC3M-1. DTC3B and flat surgical masks color pink, blue, white,
green, yellow, orange are substantially equivalent is safety and effectiveness to the predicate
device.
Aearo Company- K041855 Pleated plus 1050 and 1050S
Gerson Isolair Compay -K960778 APR Type N95 model 2735
Tucker & Associates company-K022256 Surgical face masks white, yellow, pink, blue and green
For reference: FXX, 878,4040. Class II
Manufacturer
Shanghai Dasheng Health Products
Aearo Company
Manufacture Co.,Ltd
Predicate device-for reference
Device
DTC3B N95 Surgical Mask
Pld
p
1
and 1050S
(New~device)
510K Number
K041855
Product code
MSH, 878.4040
SAME
Device
1.
N95 Class Particuliar respirator
1.
N95 Class Particuliar respirator
Description
2.
Multi-layer filteirng media
2.
Multi-layer filteirng media
(white polypropylene spundbond, Non-woven
(White
spundbond
polypropylene,
PP Micro fiber meltblown, polypropylene,
meltblown polypropylene)
polypropylene)
3.
Tie wire nose piece
3.
Plastic nose wire
4.
White elastic headband
4.
White elastic headband
5.
Dimension
5.
Dimension
Small (13.5" circumference)
15.5" circumference
Large(15.5" circumference)
6.
Flat pleated mask
6.
Flat pleated mask
7.
Single elastic head strap
7.
[ual
elastic head strap
certificatIOSH
TC-84A-4336
TC-84A-2630
certfiacation#
Manufacturer
Shanghai Dasheng Health Products
Gerson Isolair APR Company
Manufacture Co.,Ltd
Predicate device-for reference
Device
DTC3M-1 N95 Surgical Mask
_____________
(New device)
~~~~~N95
model 2735
(New device)
510K Number
K960778
Product code
MSH, 878.4040
SAME
Device
1.
N95 Class Particuliar respirator
1.
N95 Class Particuliar respirator
Description
2.
Multi-layer filteirng media
2.
Multi-layer filteirng media
(white polypropylene, non-woven PP micro
(White nonwoven polyester meltblown
fiber melthiown, Terylene)
polypropylene)
3.
Plastic nose wire
3.
Plastic nose wire
4.
Natural rubber, latex free
4.
Yellow elastic, latex free
5.
Dimension
5.
Dimension
15.75" circumference
Small (13.75" circumference)
6.
Molded Cup
6.
Molded Cup
7.
Dual elastic head strap
7.
Dual elastic head strap
ceNI~OSH
TC-84A-4331
TC-84A-160
certification#
and
|
.|
NIOSH
\
BFM000116094
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 54 of 60
PageID# 2569
Shanghai Dasheng Health Products Manufacture Co.,Ltd KOI0131
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page 3 of 3
Manufacturer
Shanghai'Dashing Health Products
Manufacture Co.,Ltd
Tucker & Associates company for
Predicate device-for reference
Device
Flat surgical mask white, yellow, pink, blue,
orange, green(New device)
Surgical Face Mask colors; white, yellow,
pink, blue and green
510K Number
K0777S6
Product code
MSH, 878.4040
SAME
Device
Description
1. Multi-layer filteirng media
2. Plastic nose wire
3. Flat pleated
4. loops or strips
I. Multi-layer filteirng media
2. Plastic nose wire
3. Flat pleated
4. loops or strip
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence are
as follows: -
I.
NIOSH, Exhalation of Resistance Test 84.180
II.
NIOSH Inhalation of Resistance Test, 84.180
NIOSH Sodium Chloride (Nad) -N95 84.181
IV.
Flammibility, Complied with 16 CFR 1610 Class I,
V.
Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the
aforementioned test standard.
Disscussion of Clinical Tests Performed.
Not Applicable
7. Conclusions
DS N95 Surgical Masks, DTC3M-1, DTC3B and flat surgical masks have the same
intended use and technology characterisitics as the predicate devices (K041855,
IC960778, K022256). Moreover, the bench testing contained in this submission
supplied domonstrate that the technological characterisistics do not raise any new
question of safety or effectiveness.
DS N95 Surgical Masks, DTC3M-1, DTC3B and flat surgical masks are substantially
equivalent to the predicate devices.
3
CONFIDENTIAL
BFM000116095
Shanghai Dasheng Health Products Manufacture Co.,Ltd KLolo3I1
No.228 Shihui Road, Zhongshan Street, Songjiang District, Shanghai
Tel: 86-21-57783126
Fax: 86-57784148
Page 3 of 3
Manufacturer
Shanghai'Dashing Health Products
Tucker & Associates company for
Manufacture Co.,Ltd
Predicate device-for reference
Device
Flat surgical mask white, yellow, pink, blue,
Surgical Face Mask colors; white, yellow,
orange, green(New device)
pink, blue and green
510K Number
K022256
Product code
MSH, 878.4040
SAME
Device
1.
Multi-layer filteirng media
1. Multi-layer filteirng media
Description
2. Plastic nose wire
2.
Plastic nose wire
3. Flat pleated
3.
Flat pleated
4.
loops or strips
4.
loops or strip
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence are
as follows:
-
I.
NIOSH, Exhalation of Resistance Test 84.180
II.
NIOSH Inhalation of Resistance Test, 84.180
Ill.
NIOSH Sodium Chloride (Nad) -N95 84.181
IV.
Flammubility, Complied with 16 CFR 1610 Class I,
V.
Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the
aforementioned test standard.
Disscussion of Clinical Tests Performed.
Not Applicable
7. Conclusions
DS N95 Surgical Masks, DTC3M-1, DTC3B and flat surgical masks have the same
intended use and technology characterisitics as the predicate devices (K041855,
1(960778, K022256). Moreover, the bench testing contained in this submission
supplied domonstrate that the technological characterisistics do not raise any new
question of safety or effectiveness.
DS N95 Surgical Masks, DTC3M-1, DTC3B and flat surgical masks are substantially
equivalent to the predicate devices.
3
.
BFM000116095
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 55 of 60
PageID# 2570
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
APR 2 7 2009
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Ms. Maggie Thong
Shanghai Dasheng Health Products
Number 228 Shihui Road Zhongshan Street
Songjiang District
Shanghai, CHINA
Re: K090131
Trade/Device Name: DS N95 Surgical Masks and Flat Surgical Masks for
Single Use
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: II
Product Code: MSH, FXX
Dated: April 8, 2009
Received: April 13, 2009
Dear Ms. Thong:
•
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the
indications for use stated in the enclosure) to legally marketed predicate devices marketed in
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device
Amendments, or to devices that have been reclassified in accordance with the provisions of
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. The general controls provisions of the Act include
requirements for annual registration, listing of devices, good manufacturing practice,
labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class H (Special Controls) or class III
(PMA), it may be subject to additional controls. Existing major regulations affecting your
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
addition, FDA may publish further announcements concerning your device in the Federal
Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not
mean that FDA has made a determination that your device complies with other requirements
of the Act or any Federal statutes and regulations administered by other Federal agencies.
CONFIDENTIAL
BFM000116096
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
APR27 2009
Rockville MD 20850
Ms. Maggie Zhong
Shanghai Dasheng Health Products
Number 228 Shihui Road Zhongshan Street
Songjiang District
Shanghai, CHINA
Re: K090131
Trade/Device Name: DS N95 Surgical Masks and Flat Surgical Masks for
Single Use
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: II
Product Code: MSH, FXX
Dated: April 8, 2009
Received: April 13, 2009
Dear Ms. Zhong:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the
indications for use stated in the enclosure) to legally marketed predicate devices marketed in
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device
Amendments, or to devices that have been reclassified in accordance with the provisions of
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket
approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. The general controls provisions of the Act include
requirements for annual registration, listing of devices, good manufacturing practice,
labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class 1H (Special Controls) or class III
(PMA), it may be subject to additional controls. Existing major regulations affecting your
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
addition, FDA may publish further announcements concerning your device in the Federal
Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not
mean that FDA has made a determination that your device complies with other requirements
of the Act or any Federal statutes and regulations administered by other Federal agencies.
SERVICES
Us,
BFM000116096
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 56 of 60
PageID# 2571
Page 2- Ms. Zhong
You must comply with all the Act's requirements, including, but not limited to: registration
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of
the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please contact the Center for Devices and Radiological Health's (CDRH's) Office of
Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by
reference to premarket notification" (21CFR Part 807.97). For questions regarding the
reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the
CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-
276-3464. For more information regarding the reporting of adverse events, please go to
http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free
number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
t9.
Susan Runner, D.D.S., MA
Acting Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
CONFIDENTIAL
BFM000116097
Page 2- Ms. Zhong
You must comply with all the Act's requirements, including, but not limited to: registration
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
and if applicable, the electronic product radiation control provisions (Sections 531-542 of
the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),
please contact the Center for Devices and Radiological Health's (CDRH's) Office of
Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by
reference to premarket notification" (21CFR Part 807.97). For questions regarding the
reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the
CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-
276-3464. For more information regarding the reporting of adverse events, please go to
http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free
number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner, D.D.S., MA
Acting Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
Rem
fa
BFM000116097
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 57 of 60
PageID# 2572
510(k) Number:
(Div lion Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
Attachment A
INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K 0 7
1 _ 3
APPLICANT:
Shanghai Dasheng Health Products Manufacture Co..Ltd
DEVICE NAME:
ps N95 Surgical Masks and Flat Surgical Masks for single use
DTC3M-7. DTC3B Surgical N95 Respirator
DS Surgical Ear- Loop Masks - Blue(FE3BL FinkLFE3P1. GreenfFE3G1. YellowIFE3Y1. WhitefFE3WL OrangefFE30)_
ps Surgical Fog Free Ear-Loop Masks- BluelFF3B-OL Fink1FE3F-01. Green(FFIG-01. WhifrIFT3W-01. Orange(FE30-0). Yellow(FE3Y-01
pc Surgical Ear-L000 Mat with splash visor - Blue fFE3B-AL PinkfFE3F-M. OrangefFE30-At white (FE3W-Al Yellow(FE3Y-A). GreeniFFIG-M
PS Surgical Tie-On Masks - Blue(FT3B1. l'ink(FTW) CreerifFTIC). Yellow(MYL White(FT3W1. orange(FT30)_
ps Surgical Fog Free Tie-On Masks - Blue!FEW-C). PinkiF13P-a. Green(FT1G-01 Yellow(FT3Y-0). WhitefFTIW-01. OrangefFT30-01
INDICATION FOR USE:
The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks are intended for single use by
operating room personnel and other health care workers to protect both the patients and the health care
workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.
Prescription Use
AND/OR Over-The-Counter Use X
(Part 21 CM 801 Subpart D)
(21 CM 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
CONFIDENTIAL
BFM000116098
Attachment A
INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): K /
1 3)
APPLICANT:
Shannghai Dasheng Health Products Manufacture Co..Ltd
DEVICE NAME:
DS N95 Surgical Masks and Flat Surgical Masks for single use
DTC3M-1. DTC3BSureicl N95 Respirator
DS Surgical Ear- Looo Masks - BluefFE3BX. PinktFE3Pt Green(FE3G. YeIlowIFE3Y). WhiteFR3WY. OrangefFE30O
DS Sureical Foe Free Ear-Loon Masks- BluefFE3B-O
Pink(FESP-O. GreenIFM-\
WhiteIFEW-OL. OrngeeFE3O-OV
Yellow(FRY-OQ.
DS Surwical Ear-Loop Masks with splash visor - Blue(FE3B-A). Pink(Pf3P-A). OranrefFE30-A). whitefFE3W-AV Yellow FESY-A).
GreerngFE3GA-
DS Swurocal Tie-On Masks - BlueFMT3BL Pink(Fl3P. Green(f)DG). YellowFM3YL) Whitef3WI. orange(FT3O0
'; Surecal Foa Free Tie-On Masks -BluefgfBP-O). PinkIFT3P-O'.
Green fC3G-O\. Yellowafl3Y-O). WhlitealflW-OY.
Oran
flT3O-O)
DS Surgical Tie-On Mlasks with splash visor -Bluefl'r3B-AL WhitefFTMW-A.
Oran_&eFfl0-A). Ye1IowtFT3Y-A). PinJkflP-A. Green(FT3G-A~
INDICATION FOR USE:
The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks are intended for single use by
operating room personnel and other health care workers to protect both the patients and the health care
workers from transfer of microorganisms, blood fnd body fluids, and airborne particulate materials.
Prescription Use
AND/OR Over-TheCounter Use
X
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrrence of CDRH, Office of Device Evaluation (ODE)
Page lof
·Division of fiesthGolg.
oGeneral Hospital
Intectiof Control, Dental Devices
510(k) Number:
( 9
3
Division Sign-Off)
BFM000116098
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 58 of 60
PageID# 2573
People's Republic of China Medical Device Registration Certificate
(In Vitro Diagnosis Test)
Registration No.: GuoXieZhuZhun 20203400176
Registrant Company
Guangzhou Wondfo Biotech Co., Ltd.
Registrant Address
No. 8 Lizhishan Road, Science City, Luogang District, 510663,
Guangzhou, P.R. China
Manufacturing Address
No. 8 Lizhishan Road, Science City, Luogang District, 510663,
Guangzhou, P.R. China
Agent
None
Agent Address
None
Product Name
SARS-CoV-2 Antibody Test (Lateral flow method)
Package Specification
Cassette: 1 test/pouch, 1 test/kit, 10 tests/kit, 20 tests/kit, 25 tests/kit,
30 tests/kit, 40 tests/kit, 50 tests/kit.
Main Content
Test cassette, sample diluent (dropping bottle) and sample dropper.
(See the instructions for details).
Intended Use
This product is an immunochromatographic assay for rapid,
qualitative detection of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) IgG/IgM antibody in human whole
blood, serum or plasma sample. The test is to be used as an aid in the
diagnosis of coronavirus infection disease (COVID-19), which is
caused by SARS-CoV-2. The test provides preliminary test results.
Negative results don't preclude SARS-CoV-2 infection and they
cannot be used as the sole basis for treatment or other management
decision.
Appendix
Product Specifications, Instructions
Storage and Shelf Life
Store the cartridges and buffer at 2-30°C, the shelf life is tentatively
determined to be 6 months.
Other content
None
Remark
Registrant are required to finish the following tasks after product
launch:
1. This product is only a supplementary diagnosis and emergency
reserve for pneumonia infected by COVID-19. The registration
certificate is valid for 1 year.
2. When renewing registration, a summary report of clinical
application data should be submitted in accordance with the
CONFIDENTIAL
BFM000116099
People’s Republic of China Medical Device Registration Certificate
(In Vitro Diagnosis Test)
Registration No.: GuoXieZhuZhun 20203400176
Registrant Company
Guangzhou Wondfo Biotech Co., Ltd.
Registrant Address
No. 8 Lizhishan Road, Science City, Luogang District, 510663,
Guangzhou, P.R. China
Manufacturing Address
No. 8 Lizhishan Road, Science City, Luogang District, 510663,
Guangzhou, P.R. China
Agent
None
Agent Address
None
Product Name
SARS-CoV-2 Antibody Test (Lateral flow method)
Package Specification
Cassette: 1 test/pouch, 1 test/kit, 10 tests/kit, 20 tests/kit, 25 tests/kit,
30 tests/kit, 40 tests/kit, 50 tests/kit.
Main Content
Test cassette, sample diluent (dropping bottle) and sample dropper.
(See the instructions for details).
Intended Use
This product is an immunochromatographic assay for rapid,
qualitative detection of severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) IgG/IgM antibody in human whole
blood, serum or plasma sample. The test is to be used as an aid in the
diagnosis of coronavirus infection disease (COVID-19), which is
caused by SARS-CoV-2. The test provides preliminary test results.
Negative results don’t preclude SARS-CoV-2 infection and they
cannot be used as the sole basis for treatment or other management
decision.
Appendix
Product Specifications, Instructions
Storage and Shelf Life
Store the cartridges and buffer at 2-30℃, the shelf life is tentatively
determined to be 6 months.
Other content
None
Remark
Registrant are required to finish the following tasks after product
launch:
1. This product is only a supplementary diagnosis and emergency
reserve for pneumonia infected by COVID-19. The registration
certificate is valid for 1 year.
2. When renewing registration, a summary report of clinical
application data should be submitted in accordance with the
BFM000116099
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 59 of 60
PageID# 2574
following requirements: continuous clinical application data of the
product should be collected at 3 or more clinical medical institutions
(including centers for disease control and prevention at all levels).
The clinical application data should be completed, the sample size
should meet the statistical requirements, and the signature and seal
should meet the requirements.
3. The enterprise shall finish all registration application materials in
accordance with In Vitro Diagnostic Reagent Registration
Management Method when renewing registration.
Approved by: National Medical Products Administration
Approval Date: 22nd February 2020
Valid Until: 21st February 2021
CONFIDENTIAL
BFM000116100
following requirements: continuous clinical application data of the
product should be collected at 3 or more clinical medical institutions
(including centers for disease control and prevention at all levels).
The clinical application data should be completed, the sample size
should meet the statistical requirements, and the signature and seal
should meet the requirements.
3. The enterprise shall finish all registration application materials in
accordance with In Vitro Diagnostic Reagent Registration
Management Method when renewing registration.
Approved by: National Medical Products Administration
Approval Date: 22nd February 2020
Valid Until: 21st February 2021
BFM000116100
CONFIDENTIAL
Case 1:20-cv-00658-LMB-IDD Document 132-8 Filed 05/07/21 Page 60 of 60
PageID# 2575