3M Company v. Performance Supply — Performance Supply Formal Quote to NYC (Exhibit 9)
- Date
- 2020-04-24
Summary
Exhibit 9, filed April 24, 2020 as Document 15-9 in Case 1:20-cv-02949-JLR-JW, 3M Company v. Performance Supply, is a 15-page exhibit that opens with a Performance Supply LLC formal quote addressed to a buyer in the NYC Office of Citywide Procurement. The quote offers 3M Particulate Respirator 8210 N95 masks, quantity 2 Million at $6.05/mask, and 3M Health Care Particulate Respirator 1860 N95 masks, quantity 5 Million at $6.35/mask, with no upfront deposit and shipment at 3M's discretion. Attached are 3M product data sheets and user instructions for both models, a NIOSH list of approved N95 respirators, and material on the FDA's March 25, 2020 temporary enforcement policy. The exhibit closes with a quality assurance review dated 3-31-2020 finding the submitted mask specifications substantially in compliance with the NYC Specification.
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Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 1 of 15
EXHIBIT 9
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 2 of 15
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-8210-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
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 3 of 15
3M™ Particulate Respirator
8210, N95
Key Features
• NIOSH approved N95 rating
• Adjustable nose clip
• Nose foam
• Ultrasonically welded headbands
Material Composition
• Straps – Thermoplastic Elastomer
Do Not Use For
• Nose Clip – Aluminum
• DO NOT use for gases and vapors, oil
• Nose foam - Polyurethane
aerosols, asbestos, arsenic, cadmium,
• Filter – Polypropylene
lead, 4,4-methylene dianiline (MDA), or
• Shell – Polyester
abrasive blasting
• Coverweb - Polyester
• DO NOT use for particulate
• This respirator contains no components
concentrations exceeding 10X PEL/OEL
made from natural rubber latex
• DO NOT use in any manner not indicated
• Approximate weight of product: 0.35 oz.
in the User Instructions
Country of Origin
Approvals and Standards
Made in the USA with globally sourced
• NIOSH approved N95 particulate
materials
respirator
Use For • Meets NIOSH 42 CFR 84 N95
• Use for solid particulates and liquid mists requirements for a minimum 95%
in concentrations not exceeding 10X filtration efficiency against solid and
PEL/OEL liquid aerosols that do not contain oil.
• Always follow User Instructions and use • NIOSH approval number: TC-84A-0007
in manners as indicated • Assigned Protection Factor (APF 10) per
US OSHA and Canada CSA
Ordering Information
Respirators/
Description UPC ID # Boxes/Case Each/Case
Box
Particulate
Respirator 50051138464573 70-0706-1439-4 20 8 160
8210
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 4 of 15
Time Use Limitation Acceptable Fit Test Protocols
Replace the respirator when it becomes
dirty, damaged, or difficult to breathe Acceptable with
Fit Test Protocol*
through. this product?
Saccharin ☒
Shelf Life and Storage
• 5 years from the date of manufacture BitrexTM ☒
• Use By date on box in MM/YYYY format Qualitative
Protocols Irritant
• Store respirators in the original ☐
Smoke
packaging, away from contaminated Isoamyl
areas, dust, sunlight, extreme Acetate
☐
temperatures, excessive moisture, and
damaging chemicals Quantitative Protocols ☒
• Store in temperatures between -4°F *Refer to OSHA 1910.134
(-20°C) and +86°F (+30°C) and not
exceeding 80% RH
WARNING!
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
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 Instructions 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
For More Information
St. Paul, MN 55144-1000
Technical Assistance 1-800-243-4630
3M.com/workersafety
Hours of Operation: M-Th 8am - 6pm, Fri 8am - 4:30 pm CST
© 3M 2018. All rights reserved.
3M PSD products are occupational use only.
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 5 of 15
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 I
• Adjustable nose clip
• Braided and stapled headbands
Material Composition
• Straps – Braided Polyisoprene
• Staples - Steel
• Nose Clip – Aluminum
Do Not Use For
• Nose Foam – Polyurethane Foam
• DO NOT use in industrial settings
• Filter – Polypropylene
• DO NOT use for gases or vapors (i.e.
• Shell – Polyester
anesthetic gases such as isoflurane or vapors
• Coverweb - Polypropylene
from sterilants such as glutaraldehyde.)
• Not made with natural rubber latex
• DO NOT use in any manner not indicated in the
• Approximate weight of product: 0.40 oz.
User Instructions
Country of Origin
Approvals and Standards
Made in the USA with globally sourced materials
• NIOSH approved N95 respirator
Use For • Meets NIOSH 42 CFR 84 N95 requirements
• Intended to be worn by operating room for a minimum 95% filtration efficiency against
personnel during surgical procedures to help solid and liquid aerosols that do not contain oil.
protect both the surgical patient and the • NIOSH approval number: TC-84A-0006
operating room personnel from transfer of • FDA cleared for use as a surgical mask
microorganisms, body fluids, and particulate • Health Canada Class I medical device
material. • Bacterial Filtration Efficiency F2101 >99% BFE
• Always follow User Instructions and use in • Assigned Protection Factor (APF 10) per US
manners as indicated OSHA and Canada CSA
Ordering Information
Respirators/
Description UPC ID # Boxes/Case Each/Case
Box
Health Care
Particulate
50707387419429 70-0706-1236-4 20 6 120
Respirator,
1860
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 6 of 15
Time Use Limitation Acceptable Fit Test Protocols
Respirator may be used until damaged, breathing
becomes difficult or contaminated with blood or Acceptable with this
Fit Test Protocol*
body fluids. Discard after every use when used for product?
surgical procedures. Follow national, state, local, Saccharin ☒
and facility infection control guidance and policies. BitrexTM ☒
Qualitative
Shelf Life and Storage Protocols Irritant
☐
• 5 years from the date of manufacture Smoke
• Use By date on box in YYYY-MM-DD format Isoamyl
☐
• Store respirators in the original packaging, Acetate
away from contaminated areas, dust, sunlight, Quantitative Protocols ☒
extreme temperatures, excessive moisture, and
damaging chemicals *Refer to OSHA 1910.134
• Store in temperatures between -4°F
(-20°C) and +86°F (+30°C) and not exceeding
80% RH
WARNING!
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 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 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 Instructions, 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
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-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 7 of 15
The National Personal Protective Technology Laboratory
(NPPTL)
NIOSH-Approved N95 Particulate Filtering Facepiece
Respirators
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 ltering facepiece respirators. This product lters 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 rst 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 de nition 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 o cial endorsement of their content, or as a statement of NIOSH policy.
Index: 3M A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Notes
Model
Supplier/Manufacturer and Contact Number/Product Approval Valve Manufacturer’s Donning
Information Line Number Yes/No Procedure User Instructions
3M Company 1860 (FDA) 84A-0006 No 1860, 1860S [PDF – 72 KB]
888-3M HELPS or web form 1860S (FDA)
(Distribution Availability )
3M Company 8110S 84A-0007 No 8210 [PDF – 103 KB]
888-3M HELPS or web form 8210 8110S, 8210, 7048 [PDF – 187
(Distribution availability for all 8210 Plus KB]
products listed for 3M ) 8216
8217
7048
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 8 of 15
3 3044
page 1 of 2
Particulate Respirators
8210 and 8110S, N95
Issue Date 01/01/04
The 3MTM Particulate Respirator
8210, N95 is designed to help
provide quality, reliable worker
protection against certain non-oil
based particles. The 3MTM
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
• At least 95% filtration efficiency
against solid and liquid aerosols that
do not contain oil.* TC-84A-0007
Advanced Electret Media
• Advanced electrostatically charged
microfibers make breathing easier
and cooler.
3MTM Particulate Respirator 8210, N95
Helps provide worker protection (Inset photo: 3MTM Particulate Respirator 8110S, N95)
• Because they are comfortable to
wear and easy to use, workers are Suggested Applications
quick to accept and use maintenance-
free respirators, like the 8210 and • Grinding
8110S. Studies have shown they can • Sanding
provide protection equivalent to a • Sweeping
rubber facepiece respirator…at much • Bagging ! WARNING
lower cost and greater convenience. • Other dusty These respirators help reduce exposure to certain
particles. Misuse may result in sickness or death.
Lightweight construction operations Before use, the wearer must read and understand
• Woodworking User Instructions provided as a part of product
• Promotes greater worker comfort. packaging. Time use limitations may apply. For
• Contributes to increased wear time. • 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.
Adjustable noseclip
• Helps provide a custom fit
and secure seal.
• Reduces the potential for
eyewear fogging.
*Tested against particles approximately 0.3 micron in size (mass median aerodynamic diameter) per 42 CFR 84.
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 9 of 15
3044
3MTM Particulate Respirators 8210 and 8110S, N95 page 2 of 2
Respirators Per Box Technologies
8210 & 8110S Respirators Per Case
20 160
Use For: Important
• Solids such as those from Before using these respirators, Advanced Electret Media
Advanced electrostatically charged
processing minerals, coal, you must determine the following: microfibers make breathing easier
iron ore, flour, and certain 1. The type of contaminant(s) and cooler.
other substances. for which the respirator is
• Liquid or non-oil based being selected. Additional Information
particles from sprays that do 2. The concentration level This respirator contains no
not also emit harmful vapors. of contaminant(s). components made from natural
3. Whether the respirator can be rubber latex.
Do Not Use For:
properly fitted on the wearer’s
Gases and vapors, including those
face. Do not use with beards,
present in paint spray operations,
on other facial hair, or other
asbestos, arsenic, cadmium, lead,
conditions that prevent a good
4,4'-methylenedianiline (MDA) or
seal between the face and the
sandblasting. Aerosol concentrations
faceseal of the respirator.
that exceed 10 times the OSHA
4. Before use of these respirators, For more information, please contact:
PEL, or applicable exposure
a written respiratory protection
limits, whichever is lower. This 3M Occupational Health and
program must be implemented, Environmental Safety Division
respirator does not supply oxygen.
meeting all the requirements (OH&ESD)
of OSHA 29 CFR 1910.134, In the U.S., contact:
including training, medical Sales Assistance
1-800-896-4223
evaluation and fit testing.
Technical Assistance
1-800-243-4630
Time Use Limitation Fax On Demand
1-800-646-1655
If respirator becomes damaged, Internet
soiled, or breathing becomes http://www.3M.com/occsafety
difficult, leave the contaminated For other 3M products
1-800-3M HELPS
area immediately and dispose of
the respirator. 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
3M Occupational Health and Environmental Safety Division 0800-132333
3M Center, Building 235-2W-70 Fax On Demand O.U.S. Locations
1-651-732-6530
St. Paul, MN 55144-1000
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 10 of 15
Health Care
Particulate Respirator
and Surgical Mask
User Instructions
(Keep these instructions for reference)
Meets CDC guidelines for Mycobacterium tuberculosis exposure control.
1860/1860S
1
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 11 of 15
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 oil1. 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 2 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.
1
Tested against a 0.3 micron particle (count median diameter) per 42 CFR 84.
2
Bacterial Filtration Efficiency (BFE) determined by the modified Greene and Vesley test method.
2
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 12 of 15
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 Fitting 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.
3
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 13 of 15
NIOSH Approved: N95
At least 95% filtration efficiency against solid and liquid aerosols that do not contain oil.
3M
ST. PAUL, MN, USA
1-800-243-4630
THIS RESPIRATOR IS APPROVED ONLY IN THE FOLLOWING CONFIGURATION:
TC- Protection 1 Respirator Cautions and Limitations 2
1860 1860S
84A-0006 N95 X X ABCJMNOP
1. PROTECTION
N95 - Particulate Filter (95% filter efficiency
level) effective against particulate aerosols
free of oil; time use restrictions may apply
2. CAUTIONS AND LIMITATIONS
A - Not for use in atmospheres containing less than 19.5 percent oxygen.
B - Not for use in atmospheres immediately dangerous to life or health.
C - Do not exceed maximum use concentrations established by regulatory standards.
J - Failure to properly use and maintain this product could result in injury or death.
M - All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, OSHA, and other applicable regulations.
N - Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as specified by the manufacturer.
O - Refer to user's instructions, and/or maintenance manuals for information on use and maintenance of these respirators.
P - NIOSH does not evaluate respirators for use as surgical masks.
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
4
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 14 of 15
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)
Case 1:20-cv-02949-JLR-JW Document 15-9 Filed 04/24/20 Page 15 of 15
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)
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