Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 Page 1 of 15
`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 Page 1 of 15
`
`EXHIBIT 8
`
`EXHIBIT 8
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 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 Document 1-8 Filed 04/10/20 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
`• Nose Clip – Aluminum
`• Nose foam - Polyurethane
`• Filter – Polypropylene
`• Shell – Polyester
`• Coverweb - Polyester
`• This respirator contains no components
`made from natural rubber latex
`• Approximate weight of product: 0.35 oz.
`Country of Origin
`Made in the USA with globally sourced
`materials
`
`Use For
`• Use for solid particulates and liquid mists
`in concentrations not exceeding 10X
`PEL/OEL
`• Always follow User Instructions 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 Instructions
`
`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
`
`Description
`
`UPC
`
`Ordering Information
`Respirators/
`Box
`
`ID #
`
`Boxes/Case
`
`Each/Case
`
`Particulate
`Respirator
`8210
`
`50051138464573 70-0706-1439-4
`
`20
`
`8
`
`160
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 Page 4 of 15
`
`Acceptable Fit Test Protocols
`
`Fit Test Protocol*
`
`Saccharin
`BitrexTM
`
`Qualitative
`Protocols
`
`Irritant
`Smoke
`Isoamyl
`Acetate
`Quantitative Protocols
`
`Acceptable with
`this product?
`☒
`
`☒
`
`☐
`
`☐
`
`☒
`
`*Refer to OSHA 1910.134
`
`
`
`
`
`
`
`Time Use Limitation
`Replace the respirator when it becomes
`dirty, damaged, or difficult to breathe
`through.
`
`Shelf Life and Storage
`• 5 years from the date of manufacture
`• Use By date on box in MM/YYYY format
`• Store respirators in the original
`packaging, away from contaminated
`areas, dust, sunlight, extreme
`temperatures, excessive moisture, and
`damaging chemicals
`• Store in temperatures between -4°F
`(-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
`St. Paul, MN 55144-1000
`3M.com/workersafety
`
`3M PSD products are occupational use only.
`
`
`
`For More Information
`Technical Assistance 1-800-243-4630
`Hours of Operation: M-Th 8am - 6pm, Fri 8am - 4:30 pm CST
`© 3M 2018. All rights reserved.
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 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
`• 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
`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.
`• Always follow User Instructions 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 I medical device
`• Bacterial Filtration Efficiency F2101 >99% BFE
`• Assigned Protection Factor (APF 10) per US
`OSHA and Canada CSA
`
`
`
`Description
`
`UPC
`
`Ordering Information
`Respirators/
`Box
`
`ID #
`
`Boxes/Case
`
`Each/Case
`
`Health Care
`Particulate
`Respirator,
`1860
`
`50707387419429
`
`
`70-0706-1236-4
`
`
`20
`
`6
`
`120
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 Page 6 of 15
`
`Acceptable Fit Test Protocols
`
`Fit Test Protocol*
`
`Acceptable with this
`product?
`
`Saccharin
`BitrexTM
`
`Qualitative
`Protocols
`
`Irritant
`Smoke
`Isoamyl
`Acetate
`Quantitative Protocols
`
`*Refer to OSHA 1910.134
`
`
`
`
`☒
`
`☒
`
`☐
`
`☐
`
`☒
`
`
`
`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
`• 5 years from the date of manufacture
`• Use By date on box in YYYY-MM-DD format
`• Store respirators in the original packaging,
`away from contaminated areas, dust, sunlight,
`extreme temperatures, excessive moisture, and
`damaging chemicals
`• 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
`
`1-800-228-3957
`3M.com/medical
`
`
`
`
`
`3M is a trademark of 3M Company
`Please recycle. Printed in U.S.A
`© 3M 2017. All rights reserved.
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 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 denition 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 ocial 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
`
`Supplier/Manufacturer and Contact
`Information
`
`3M Company
`
`888-3M HELPS or web form
`(Distribution Availability
`)
`
`
`
`
`3M Company
`
`888-3M HELPS or web form
`
`(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
`
`Valve
`Yes/No
`
`Manufacturer’s Donning
`Procedure User Instructions
`
`84A-0006
`
`No
`
`1860, 1860S [PDF – 72 KB]
`
`
`
`84A-0007
`
`No
`
`8210 [PDF – 103 KB]
`
`8110S, 8210, 7048 [PDF – 187
`KB]
`
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 Page 8 of 15
`
`3
`Particulate Respirators
`8210 and 8110S, N95
`
`3044
`page 1 of 2
`
`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.
`
`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
`• 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.
`
`3MTM Particulate Respirator 8210, N95
`(Inset photo: 3MTM Particulate Respirator 8110S, N95)
`
`Suggested Applications
`
`• Grinding
`• Sanding
`• Sweeping
`• Bagging
`• Other dusty
`operations
`• Woodworking
`• Foundries
`
`WARNING
`!
`These respirators help reduce exposure to certain
`particles. Misuse may result in sickness or death.
`Before use, the wearer must read and understand
`User Instructions provided as a part of product
`packaging. Time use limitations may apply. For
`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.
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 Page 9 of 15
`
`3MTM Particulate Respirators 8210 and 8110S, N95
`
`3044
`page 2 of 2
`
`Respirators Per Box
`8210 & 8110S
`
`20
`
`Respirators Per Case
`
`160
`
`Technologies
`
`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
`
`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
`
`

`

`Case 1:20-cv-02949 Document 1-8 Filed 04/10/20 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 Document 1-8 Filed 04/10/20 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 Document 1-8 Filed 04/10/20 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 Document 1-8 Filed 04/10/20 Page 13 of 15
`
`NIOSH Approved: N95
`At least 95% filtration efficiency against solid and liquid aerosols that do not contain oil.
`
`3 M
`ST. PAUL, MN, USA
`1 - 8 0 0 - 2 4 3 - 4 6 3 0
`
`THIS RESPIRATOR IS APPROVED ONLY IN THE FOLLOWING CONFIGURATION:
`Protection 1
`Respirator
`TC-
`1860
`1860S
`X
`X
`
`8 4 A - 0 0 0 6
`
`N95
`
`Cautions and Limitations 2
`
`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 Document 1-8 Filed 04/10/20 Page 14 of 15
`
`Evaluation Request- Bid Document Review
`Technical Services/Quality Assurance
`
`
`
`EBONY P ROBERSON
`
`Procurement Analyst
`
`
`RASHAD LE MONIER
`Purchase Director
`
`
`
`
`
`
`
`212-386-0466
`(EROBERSON@dcas.nyc.gov)
`Tel.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3/30/2020
`
`Date
`
`
`
`
`
`
`
`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 Document 1-8 Filed 04/10/20 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)
`
`