Exhibit 10, Performance Supply LLC Formal Quote (Document 16-10)

Summary

Exhibit 10, filed April 24, 2020 as Document 16-10 in Case 1:20-cv-02949-LAP, a 16-page exhibit centered on a formal quote from Performance Supply LLC to Ebony P. Roberson, a buyer in the Office of Citywide Procurement. The quote offers 2 million 3M 8210 N95 respirators at $6.05 per mask and 5 million 3M 1860 N95 respirators at $6.35 per mask, with no upfront deposit, payment in full net 15 days after each shipment, and shipping in 2 to 4 weeks at 3M's discretion. Purchase orders are to be addressed to Performance Supply president Ron Romano. The exhibit includes 3M technical specification sheets and a quality assurance review by analyst Daniel Ortega finding both masks substantially in compliance with the NYC Specification.

Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used

Full text

Case 1:20-cv-02949-LAP Document 16-10 Filed 04/24/20 Page 1 of 16

EXHIBIT 10
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EXHIBIT 8
Cas@ds@0k200R2899944P Doounreeshils6-leFi@d WIZ /Aageayeta.6f 16

PERFORMANCE SUPPLY LLC
FORMAL QUOTE
TO: Ms. Ebony P. Roberson
Buyer

Office of Citywide Procurement
Telephone: +1 (212) 386-0466
ERoberson@dcas .nyc.gov

1. 3M Particulate Respirator 8210, N95 160 EA/Case

Product Specification: : https://www.3m.com/3M/en_US/company-us/all-3m-products/~/3M-
Particulate-Respirator-82 10-N95-160-EA-Case/?N=5002385+3294780268 &rt=rud

2. 3M Health Care Particulate Respirator 1860, N95 120 EA/Case

Product Specification: https://www.3m.com/3M/en_US/company-us/all-3m-products/~/3M-Health-
Care-Particulate-Respirator-and-Surgical-Mask-1860-N95-120-EA-
Case/?N=5002385+3294795990&rt=rud

3. Country of Origin: TBD
4. Headquarters: St. Paul, Minnesota, USA

5. Quantity: 8210-2 Million
1860 —5 Million

6. Price: 8210 — $6.05/mask
1860 — $6.35/mask

7. Payment Terms: No upfront deposits are required. Instead, Buyer sends Purchase Order first -- and
once that is accepted by the factory — financial closing terms will be mutually agreed. Payment in full
must be made upon receipt of Each shipment Net 15 days.

8. Shipping: Due to the national emergency, acceptance of the purchase order is at the full discretion of
3M and supplies are based upon availability. The N95 masks 3M can begin shipping in 2-4 weeks
CIF at any of 3M plants in the USA or 3M Plants Overseas according to their manufacturing
schedule. 3M chooses the plant. Order may be shipped in whole or in part.

9. Buyer will not terminate or reject delivery for 3M Masks after Quality Assurance inspection and
products are authenticated, verified and meet 3M specifications which are indicated and agreed by the
formal quote and purchase order.

10. Please address Purchase Order to:

Mr. Ron Romano, President
Performance Supply, LLC
P.O. Box 672

Englishtown, NJ 07726

Via 3BP, Inc

POST OFFICE BOX 672
ENGLISHTOWN, NJ 07726
Telephone: +1 (732) 685-6403
Cas@ds20:aea29ea944P Ddounraeht16-HleFiel WI2H/Rageayef4. bf 16

Science.
Applied to Life.”

Technical Specification Sheet

3M” Particulate Respirator
8210, N95

Key Features

NIOSH approved N95 rating

e Adjustable nose clip

e Nose foam

e Ultrasonically welded headbands

Material Composition

Straps — Thermoplastic Elastomer

Nose Clip — Aluminum

Nose foam - Polyurethane

Filter — Polypropylene

Shell — Polyester

Coverweb - Polyester

This respirator contains no components
made from natural rubber latex

e Approximate weight of product: 0.35 oz.

Country of Origin
Made in the USA with globally sourced
materials

Use For

e Use for solid particulates and liquid mists
in concentrations not exceeding 10X
PEL/OEL

e Always follow User /nstructions and use
in manners as indicated

Do Not Use For

DO NOT use for gases and vapors, oil
aerosols, asbestos, arsenic, cadmium,
lead, 4,4-methylene dianiline (MDA), or
abrasive blasting

DO NOT use for particulate
concentrations exceeding 10X PEL/OEL
DO NOT use in any manner not indicated
in the User /nstructions

Approvals and Standards

NIOSH approved N95 particulate
respirator

Meets NIOSH 42 CFR 84 N95
requirements for a minimum 95%
filtration efficiency against solid and
liquid aerosols that do not contain oil.
NIOSH approval number: TC-84A-0007
Assigned Protection Factor (APF 10) per
US OSHA and Canada CSA

Ordering Information

Description

Respirators/

Each/Case
Box

Boxes/Case

Particulate
Respirator
8210

50051138464573 | 70-0706-1439-4

20 8 160

Time Use Limitation Acceptable Fit Test Protocols
Replace the respirator when it becomes ,
dirty, damaged, or difficult to breathe Fit Test Protocol* Acceptable with
through. this product?
Shelf Life and Storage Saccharin a
e 5years from the date of manufacture — BitrexTM
e Use By date on box in MM/YYYY format Qualitative :

St irators in the original Protocols Irritant oO
e ore respirators in the original Oral

packaging, away from contaminated Isoamyl :

areas, dust, sunlight, extreme Acetate

temperatures, excessive moisture, and La

damaging chemicals Quantitative Protocols x

e Store in temperatures between -4°F *Refer to OSHA 1910.134
(-20°C) and +86°F (+30°C) and not
exceeding 80% RH

WARNING! 4&

This respirator helps reduce exposures to
certain airborne contaminants. Before use,
the wearer must read and understand the
User Instructions provided as a part of the
product packaging. Follow all local
regulations. In the U.S., a written respiratory
protection program must be implemented
meeting all the requirements of OSHA
1910.134, including training, fit testing and
medical evaluation. In Canada, CSA standard
294.4 requirements must be met and/or
requirements of the applicable jurisdiction,
as appropriate. Misuse may result in
sickness or death. For correct use, consult
supervisor and the User /nstructions or call
3M PSD Technical Service in USA at 1-800-
243-4630 and in Canada at 1-800-267-
4414.

Personal Safety Division

3M Center, Building 0235-2W-70
St. Paul, MN 55144-1000
3M.com/workersafety

For More Information
Technical Assistance 1-800-243-4630
Hours of Operation: M-Th 8am - 6pm, Fri 8am - 4:30 pm CST

3M PSD products are occupational use only. © 3M 2018. All rights reserved.
Cas@ds2@0hr20a2909949P Dodouureent16- HleFi®e Wi201/Aageayefal6f 16

Science.
Applied to Life.”

Technical Specification Sheet

3M”™ Health Care Particulate
Respirator and Surgical Mask,
1860, N95

Key Features

NIOSH approved N95 rating

FDA cleared for use as a surgical mask
Fluid Resistant 120 mmHg
Flammability Rating Class |

Adjustable nose clip

Braided and stapled headbands

Material Composition

Straps — Braided Polyisoprene

Staples - Steel

Nose Clip — Aluminum

Nose Foam — Polyurethane Foam

Filter —- Polypropylene

Shell — Polyester

Coverweb - Polypropylene

Not made with natural rubber latex
Approximate weight of product: 0.40 oz.

Country of Origin
Made in the USA with globally sourced materials

Use For

e Intended to be worn by operating room
personnel during surgical procedures to help
protect both the surgical patient and the
operating room personnel from transfer of
microorganisms, body fluids, and particulate
material.

e = =Always follow User /nstructions and use in
manners as indicated

Do Not Use For

DO NOT use in industrial settings

DO NOT use for gases or vapors (i.e.
anesthetic gases such as isoflurane or vapors
from sterilants such as glutaraldehyde.)

DO NOT use in any manner not indicated in the
User Instructions

Approvals and Standards

NIOSH approved N95 respirator

Meets NIOSH 42 CFR 84 N95 requirements
for a minimum 95% filtration efficiency against
solid and liquid aerosols that do not contain oil.
NIOSH approval number: TC-84A-0006

FDA cleared for use as a surgical mask

Health Canada Class | medical device
Bacterial Filtration Efficiency F2101 >99% BFE
Assigned Protection Factor (APF 10) per US
OSHA and Canada CSA

Ordering Information

Description

ID #

Respirators/

Each/Case
Box

Boxes/Case

Health Care
Particulate
Respirator,
1860

50707387419429

70-0706-1236-4

20 6 120

Time Use Limitation

Respirator may be used until damaged, breathing
becomes difficult or contaminated with blood or
body fluids. Discard after every use when used for
surgical procedures. Follow national, state, local,
and facility infection control guidance and policies.

Shelf Life and Storage

e 5years from the date of manufacture

e Use By date on box in YYYY-MM-DD format

e Store respirators in the original packaging,
away from contaminated areas, dust, sunlight,
extreme temperatures, excessive moisture, and
damaging chemicals

e Store in temperatures between -4°F
(-20°C) and +86°F (+30°C) and not exceeding
80% RH

WARNING! A

This respirator helps protect against certain
particulate contaminants but does not eliminate
exposure to or the risk of contracting any disease
or infection. Before use, the wearer must read and
understand the User /nstructions provided as a part
of the product packaging. Follow all local
regulations. In the U.S., a written respiratory
protection program must be implemented meeting
all the requirements of OSHA 1910.134, including
training, fit testing and medical evaluation. In
Canada, CSA standard Z94.4 requirements must
be met and/or requirements of the applicable
jurisdiction, as appropriate. Misuse may result in
sickness or death. For correct use, consult
supervisor and the User /nstructions, or call 3M
Health Care in USA at 1-800-228-3957 and in
Canada at 1-800-267-4414.

Infection Prevention Division

3M Health Care
2510 Conway Avenue

Acceptable Fit Test Protocols

Fit Test Protocol*

Saccharin

Acceptable with this
product?

XJ

BitrexTM
Qualitative

Protocols _ | Irritant
Smoke

lsoamyl
Acetate

Quantitative Protocols

Oo
0
XJ

*Refer to OSHA 1910.134

St. Paul, MN 55144-1000 3M is a trademark of 3M Company
Please recycle. Printed in U.S.A
1-800-228-3957 © 3M 2017. All rights reserved.

3M.com/medical

Case 1:20-cv-03984

D “a4 Centers for Disease
f C Control and Prevention

:20-cv-02949 Document 1-8 File
-LAP_. Document 16-1

04/1

Filed

Pa

04/24/30 Page.8 of 16

The National Personal Protective Technology Laboratory

(NPPTL)

Promoting productive workplaces -
through safety and health research

NIOSH-Approved N95 Particulate Filtering Facepiece

Respirators

1) For information about Coronavirus Disease 2019, visit
https://www.cdc.gov/coronavirus/2019-ncov/index.html.

Manufacturers Listed Alphabetically — 3M

The N95 respirator is the most common of the seven types of particulate filtering facepiece respirators. This product filters at
least 95% of airborne particles but is not resistant to oil.

This web page provides a table of NIOSH-approved N95 respirators, listed alphabetically by manufacturer. You can select a
particular manufacturer by clicking on the first letter of their name on the index below.

There are some products that are approved by NIOSH as an N95 respirator and also cleared by the Food and Drug
Administration (FDA) as a surgical mask. These products are referred to as Surgical N95 Respirators. View a definition of
Surgical N95 Respirators. For your convenience the Surgical N95 Respirators are indicated with the Model Number/Product
Line in bold text followed by (FDA). If you have a product you believe is NIOSH-approved and FDA-cleared that does not
appear on this list, you will need to check with the FDA Center for Devices and Radiological Health at 1-800-638-2041 for

validation of clearance. View a comprehensive table of Surgical N95 Respirators.

Disclaimer: The links in this section go to websites outside of CDC/NIOSH and should not be considered as an endorsement of
their content, or as a statement of NIOSH policy. The donning procedure and/or user instruction, either on the websites or
the PDF version, should not be considered an official endorsement of their content, or as a statement of NIOSH policy.

Index: 3M ABCDEFGHIJKLMNOPQRSTUVWX/YZ Notes

Supplier/Manufacturer and Contact
Information

3M Company [4
888-3M HELPS or web form [4
(Distribution Availability 4 )

3M Company 4

888-3M HELPS or web form 4
(Distribution availability for all
products listed for 3M[“)

Model
Number/Product
Line

1860 (FDA)
1860S (FDA)

8110S
8210
8210 Plus
8216
8217
7048

Approval
Number

84A-0006

84A-0007

Valve
Yes/No

No

No

Manufacturer's Donning
Procedure User Instructions

1860, 1860S [PDF - 72 KB]4

8210 [PDF - 103 KB]4
8110S, 8210, 7048 [PDF - 187
KB] 4
Cas@ds@0: 2002899944P Doocunreenili6-leFi@d IZM /AageayefA.6f 16

3044
page 1 of 2

Particulate Respirators
8210 and 8110S N95

The 3M™ Particulate Respirator
8210 N95 is designed to help
provide quality reliable worker
protection against certain non-oil
based particles. The 3M™
Particulate Respirator 8110S N95
offers the same protection for
those workers with smaller faces.
The 8210 and the 8110S offer a
number of benefits to you and
your workers.

NIOSH approved N95

e Atleast 95 __ filtration efficiency
against solid and liquid aerosols that
do not contain oil.* TC-84A-0007

Advanced Electret Media

e Advanced electrostatically charged
microfibers make breathing easier
and cooler.

Helps provide worker protection

¢ Because they are comfortable to
wear and easy to use, workers are
quick to accept and use maintenance-
free respirators, like the 8210 and
8110S. Studies have shown they can
provide protection equivalent to a
rubber facepiece respirator. ..at much
lower cost and greater convenience.

Lightweight construction

e Promotes greater worker comfort.
¢ Contributes to increased wear time.
Adjustable noseclip

¢ Helps provide a custom fit
and secure seal.

¢ Reduces the potential for
eyewear fogging.

Issue Date 01/01/04

3M™ Particulate Respirator 8210, N95
(Inset photo: 3M™ Particulate Respirator 8110S, N95)

Suggested Applications
¢ Grinding
e Sanding
¢ Sweeping
» Bagging A WARNING
¢ Other dusty These respirators help reduce exposure to certain
: particles. Misuse may result in sickness or death.
operations Before use, the wearer must read and understand
¢ Woodworking User Instructions provided as a part of product
. packaging. Time use limitations may apply. For
¢ Foundries proper use, see package instructions, supervisor
or call 3M OH ESD Technical Service in U.S.A.,
1-800-243-4630. In Canada, call 1-800-267-4414.

Tested against particles approximately 0.3 micron in size mass median aerodynamic diameter) per 42 CFR 84.
Cas@aOscQP@OZ294PR04P DMumumesiiti-6-16ildel64/00/20/2BageagalLonf 16

3M™ Particulate Respirators 8210 and 8110S N95

3044
page 2 of 2

Respirators Per Box
8210 8110S

Respirators Per Case

Technologies

20

160

Use For:

¢ Solids such as those from
processing minerals, coal,
iron ore, flour, and certain
other substances.

¢ Liquid or non-oil based
particles from sprays that do
not also emit harmful vapors.

Do Not Use For:

Gases and vapors, including those
present in paint spray operations,
asbestos, arsenic, cadmium, lead,
4,4'-methylenedianiline (MDA) or
sandblasting. Aerosol concentrations
that exceed 10 times the OSHA
PEL, or applicable exposure
limits, whichever is lower. This
respirator does not supply oxygen.

Important
Before using these respirators,
you must determine the following:

1. The type of contaminant(s)
for which the respirator is
being selected.

2. The concentration level
of contaminant(s).

3. Whether the respirator can be
properly fitted on the wearer’s
face. Do not use with beards,
on other facial hair, or other
conditions that prevent a good
seal between the face and the
faceseal of the respirator.

4. Before use of these respirators,
a written respiratory protection
program must be implemented,
meeting all the requirements
of OSHA 29 CFR 1910.134,
including training, medical
evaluation and fit testing.

Time Use Limitation

If respirator becomes damaged,
soiled, or breathing becomes
difficult, leave the contaminated
area immediately and dispose of
the respirator.

3M Occupational Health and Environmental Safety Division

3M Center, Building 235-2W-70
St. Paul, MN 55144-1000

Theirs

Advanced Electret Media
Advanced electrostatically charged
microfibers make breathing easier
and cooler.

Additional Information

This respirator contains no
components made from natural
rubber latex.

For more information, please contact:

3M Occupational Health and
Environmental Safety Division
(OH ESD)

In the U.S., contact:

Sales Assistance
1-800-896-4223

Technical Assistance
1-800-243-4630

Fax On Demand
1-800-646-1655

Internet
http://www.3M.com/occsafety
For other 3M products
1-800-3M HELPS

In Canada, contact:

3M Canada Company, OH ESD
P.O. Box 5757

London, Ontario N6A 4T1

Sales Assistance
1-800-265-1840, ext. 6137
Technical Assistance (Canada only)
1-800-267-4414

Fax On Demand
1-800-646-1655

Internet
http://www.3M.com/CA/occsafety

Technical Assistance In Mexico
01-800-712-0646

5270-2255, 5270-2119 (Mexico City only)
Technical Assistance In Brazil
0800-132333

Fax On Demand O.U.S. Locations
1-651-732-6530

Cas€ds2@0:002009944P Doounreahii6- MleFi®@d MIAN /Aageage oft bf 16

Health Care
Particulate Respirator
and Surgical Mask

User Instructions
(Keep these instructions for reference)

Meets CDC guidelines for Mycobacterium tuberculosis exposure control.

1860/1860S
Cas€ds2@0:-002009944P Doounreahii6- MleFi®@d MIAN /aAagedde df21 bf 16

'. WARNING
This respirator helps protect against certain particulate contaminants but does not eliminate exposure to
or the risk of contracting any disease or infection. Misuse may result in sickness or death. For proper
use, see supervisor, or User Instructions, or call 3M in U.S.A., 1-800-247-3941. In Canada, call
Technical Service at 1-800-267-4414.

IMPORTANT
Before use, the wearer must read and understand these User Instructions. Keep these instructions for
reference.

DESCRIPTION

The 3M™ 1860 Health Care Particulate Respirator and Surgical Mask is designed to help provide
respiratory protection for the wearer. This product has a filter efficiency level of 95 _ or greater against
particulate aerosols free of oil’. It is fluid resistant, disposable and may be worn in surgery. It can fit a
wide range of face sizes.

This product contains no components made from natural rubber latex.

INTENDED USE: This product meets CDC guidelines for Mycobacterium tuberculosis exposure control.
As a respirator, it is intended to reduce wearer exposure to certain airborne particles in a size range of 0.1
to >10.0 microns, including those generated by electrocautery, laser surgery, and other powered medical
instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and
other infectious materials; when worn properly and in combination with protective eyewear, it complies
with the OSHA Bloodborne Pathogens Standard. It also provides >99 BFE’ against wearer generated
micro-organisms.

CONTRAINDICATIONS: Not for industrial use. Not for use with beards or other facial hair that
prevents direct contact between the face and the sealing surface of the respirator. OSHA has not set a
permissible exposure level for airborne biohazards.

USE INSTRUCTIONS:

1. Before use for respiratory protection, a written respiratory protection program must be implemented
meeting all requirements of OSHA 29 CFR 1910.139 and/or 1910.134 such as medical evaluation,
training and fit testing. In Canada, CSA standard Z94.4 requirements must be met. The 3M
saccharin (sweet) or Bitrix™ (bitter)qualitative fit test is recommended for this respirator. When used
only as a surgical mask, fit testing is not required.

2. Respirator may be used until damaged, breathing becomes difficult, or contaminated with blood or
body fluids. Otherwise, it may be stored and reused according to the facility’s infection control policy.

3. Filtering facepieces are to be inspected prior to each use to assure there are no holes in the breathing
zone other than the punctures around staples and no damage has occurred. Enlarged holes resulting
from ripped or torn filter material around staple punctures are considered damage. Immediately
replace respirator if damaged. Staple perforations do not affect NIOSH approval.

4. Discard after every use when used for surgical procedures.

' Tested against a 0.3 micron particle (count median diameter) per 42 CFR 84.

° Bacterial Filtration Efficiency (BFE) determined by the modified Greene and Vesley test method.
Cas@ds2@0:200R2899944P Doounreshi16- HleFid MIAN /Aageadge ofa. 6f 16

Fitting Instructions !Must be followed each time respirator is worn)

Fig. 1 Fig. 2 Fig. 3 Fig. 4

1. Cup the respirator in your hand, with the nosepiece at your fingertips, allowing the headbands to hang
freely below your hand.

2. Position the respirator under your chin with the nosepiece up. Pull the top strap over your head
resting it high at the top back of your head. Pull the bottom strap over your head and position it
around the neck below the ears.

3. Place your fingertips from both hands at the top of the metal nosepiece. Using two hands, mold the
nose area to the shape of your nose by pushing inward while moving your fingertips down both sides
of the nosepiece.

! Pinching the nosepiece using one hand may result in improper fit and less effective respirator
performance. Use two hands.

4. Perform a User Seal Check prior to each wearing. To check the respirator-to-face seal, place both
hands completely over the respirator and exhale. Be careful not to disturb the position of the
respirator. If air leaks around nose, readjust the nosepiece as described in step 3. If air leaks at the
respirator edges, work the straps back along the sides of your head.

If you CANNOT achieve proper seal, DO NOT enter the isolation or treatment area. See your
supervisor.

Removal Instructions
See step 2 of itting Instructions and cup respirator in hand to maintain position on face. Pull bottom
strap over head. Still holding respirator in position, pull top strap over head and remove respirator.
Cas€ds2@0:-a002009944P Doounreahii6- MleFi@d MIAN /Aageade di41 bf 16

NIOSH Approved: N95

Atleast 95 __ filtration efficiency against solid and liquid aerosols that do not contain oil.

ST. PAUL MN USA on

1-800-243-4630

THIS RESPIRATOR IS APPROVED ONLY IN THE FOLLOWING CONFIGURATION:
Protection ' Respirator Cautions and Limitations
1860 | 1860S
x x

84A-0006 N95 ABCJMNOP

1. PROTECTION

| NSS - Particulate Filter (05 filter efficiency
level) effective against particulate aerosols

free of oil; time use restrictions may apply

2. CAUTIONS AND LIMITATIONS

- Not for use in atmospheres containing less than 19.5 percent oxygen.

- Not for use in atmospheres immediately dangerous to life or health.

- Do not exceed maximum use concentrations established by regulatory standards.

- Failure to properly use and maintain this product could result in injury or death.

- All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, OSHA, and other applicable regulations.
- Never substitute, modify, add, or omit parts. Use only exact it parts in the confi. ion as specified by the manufacturer.

- Refer to user's instructions, and/or maintenance manuals for information on use and maintenance of these respirators.

- NIOSH does not evaluate respirators for use as surgical masks.

Cou,

vOZz=E

This respirator contains no components made from natural rubber latex.

FOR MORE INFORMATION and assistance on 3M occupational health and environmental safety
products, contact your local 3M representative or call 3M OH&ESD Technical Service toll free in U.S.A.,
1-800-243-4630. In Canada, call Technical Service at 1-800-267-4414.

Exported by/Exporté par/Exportado por:

3M Occupational Health and Environmental
Safety Division

3M Center, Building 235-2W-70

P.O. Box 33010

St. Paul, MN 55133-3010

Made in U.S.A.
©3M 2002 38-9017-7547-8
Cas€ds2@0:-002009944P Doounreahii6- MleFi®d MIAN /aAagedget ofS bf 16

Evaluation Request- Bid Document Review
Technical Services/Quality Assurance

EBONY P ROBERSON 212-386-0466 3/30/2020
(EROBERSON@dcas.nyc.gov)
Procurement Analyst Tel. Date

RASHAD LE MONIER
Purchase Director

Description of Document for Review:

Bid #: COVID-19 RELATED PURCHASE (M3 Masks — 8210 and 1860)
Title:

Specific Concerns:

To ensure that the specifications provided by the vendor adhere to all applicable standards
(FDA, CDC,NIOSH etc.) Thank you.

The vendor Performance Supply, LLC is offering the COVID-19 related purchase (M3
Masks — 8210 and 1860)

FDA creates regulatory Exemptions for Masks and respirator in response to the COVID-19
and critical PPE shortages: On March 25, 2020, the Food and Drug Administration (FDA)
issued a temporary policy relating to enforcement of regulatory requirements for face
masks and respirators during the COVID-19 crisis. Since the public health emergency
began, the United States has experienced a shortage of masks, respirators, and other
personal protective equipment (PPE) which are critically needed for health care workers
caring for COVID-19 patients in all states. FDA previously created emergency use
authorizations for NIOSH-approved disposable respirators for use in health care setting
and imported non-NIOSH-approved disposable respirators, but the temporary enforcement
policy represents an attempt to open the manufacturing, importation, and distribution flood
gates to make more masks and respirators available as quickly as possible.

The policy is limited to face mask and respirator products classified under 21 C.F.R.
&&878.4040, 880.6260 (product code FXX,OXZ,OUK,MSH,ONT,ORW, and NZJ), and
FDA divides these products into three main categories: (1) face masks and N95
respirators not intended for a medical purpose; (2) face masks intended for a medical
purpose but not to provide liquid barrier protection; and (3) surgical masks intended to
provide liquid barrier protection. Wwwmintz.com

OCP-BQA (Rev. 5/30/14)
Cas€ds2@0:-002009944P Doounreahii6- MleFi®d MIAN /aAageadde oiG.6f 16

Analysis revealed that both items: 3M Masks 1860 and 3M Masks 8210 provide
necessary protection for front line medical and non-medical personnel. Since, it is not
scientifically proven against the COVID-19; it is important to recognize that the optimal way
to prevent airborne transmission is to use a combination of interventions from across the
hierarchy of controls, not just PPE alone. Therefore, these submitted disposable 3M

Masks 1860 and 8210 specifications are substantially in compliance with the NYC
Specification.

Please - Identify commodity concerns
- Include pertinent user agency concerns and requirements

Daniel Ortega (Quality Assurance Analyst)
Date 3-31-2020

OCP-BQA (Rev. 5/30/14)

File and source

File

gov.uscourts.nysd.535588.16.10.pdf

Size

1,114,098 bytes

SHA-256

ce2eda1e5ec626cfc08e23ccecee0315e1d92432f2b5002d61fcc0cec76e9396

Our copy

gov.uscourts.nysd.535588.16.10.pdf

Original

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