How to verify trusted suppliers and buy authentic Surgical N95 respirators, NIOSH-approved N95 respirators, KN95, Surgical Masks, Medical Gowns, Medical Gloves, and Other PPE

I have been vetting non-traditional suppliers and non-FDA authorized PPE since March of 2020 for an NGO. People have asked me about my process and my knowledge base. It would be selfish to keep this workflow and knowledge to myself, so here it is. By no means, am I an expert, nor is this list comprehensive.

Outline:

  • How to evaluate vendors, manufacturers, and suppliers
  • How to evaluate for Third-Party participants
  • How to evaluate Surgical N95 respirators
  • How to evaluate NIOSH-approved N95 respirators
  • How to evaluate non-NIOSH approved respirators under the EUA
  • Additional CDC guidelines
  • How to evaluate Surgical Masks
  • How to evaluate Medical Gowns
  • How to evaluate Medical Gloves
  • How to evaluate other PPE
  • Additional EU CE regulations

Vendors

Trust is the most important item to establish with non-traditional suppliers. Hospitals and government agencies never had problems with companies like 3M or McKesson if they asked for upfront payment. COVID-19 has exposed a new problem for PPE end-users as traditional vendors have run out of supplies. We can help establish trust by verifying the prior history of non-traditional suppliers and analyzing their prior interactions.

Evaluation of the Manufacturer and Seller

  1. Name: First and Last
  2. Email: (business email – NO Yahoo, Gmail, Outlook, Aol, Hotmail, iCloud, @163, @126, @qq, @sina, etc…)
  3. Business name: 
  4. Address:
  5. Phone:
  6. Linkedin:
  7. Website:
  8. Sales catalog
  9. Price list – FOB and CIF shipping terms
  10. Quantity of stock available
  11. Amount of production capacity available
  12. Shipping time
  13. Payment terms
  14. Include all certificates and photos
  15. Factory and Produce level certification
  16. Up to the last 3 shipments or deals with end-users (hospitals, government, NGO):
  17. Standard Operating Procedure & Terms
  18. Proof FDA registered manufacturer
  19. History of company: How long manufacturing products
  20. Do you offer samples?
  21. OPTIONAL: Copy of Contract or PO with redacted sensitive data:

Third Party

Along with the information above, we will dig deeper into these third parties and their financial strength should a purchasing deal fails due to damaged product, counterfeit or failure to pay.

  1. Financial strength of intermediary: financial statement, balance sheet
  2. History with other end-users
  3. Contract: provision to protect purchase if product authenticity or quality issue: manufacturer and third party financially guarantee if issues
File:Surgical N95.jpeg - Wikipedia

Surgical N95 respirators

https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource3surgicaln95.html

  • Manufacture website for notices about counterfeit or recall
  • 3M hotline: 800-426-8688
  • FDA at 1-800-638-2041
File:2020-04-21 18 45 03 The bottom of a MCR Safety MCRN951 401 ...

NIOSH-approved N95 respirators and Surgical N95 Respirators

https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html

  • Manufacture website for notices about counterfeit or recall
  • NIOSH-approved: CDC at 1-800-CDC-INFO (1-800-232-4636)
  • FDA at 1-800-638-2041
POWERCOM KN95 Face Masks | US Medical Health

Non-NIOSH Approved Respirators Under The Emergency Use Authorizations

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe

FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic

https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-euas-non-niosh-approved-respirators-during-covid-19-pandemic

PDF of DHHS Letter: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators

https://www.fda.gov/media/136664/download

Exhibit 1: Authorized Respirators Updated: April 14, 2020 Authorized Imported, Non-NIOSH Approved Respirators Manufactured – Inactive
https://www.fda.gov/media/136731/download

Appendix A: Authorized Respirators – Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China 

https://www.fda.gov/media/136663/download

Respirator Models Removed from Appendix A Updated: May 11, 2020
https://www.fda.gov/media/137928/download

Establishment Registration & Device Listing

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

N95 Respirators and Surgical Masks (Face Masks)

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks

During Pandemic, CDC Aims to Hire Chief Data Officer - Nextgov

CDC Factors to Consider When Planning to Purchase Respirators from Another Country 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/international-respirator-purchase.html

NPPTL Respirator Assessments to Support the COVID-19 Response

https://www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

  • Must have minimum and maximum Filtration Efficacy (%) of 95% and above.
  • Visually verify products match pics sent by sellers using the PDFs

NIOSH-Approved Particulate Filtering Facepiece Respirators – ALL RESPIRATORS N95 – N100

https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/default.html

  • Mask differences (letters):
    • N95: non resistant to oil
    • R95: somewhat resistant to oil
    • P95: strongly resistant to oil
  • Mask differences (numbers):
    • N95: filters at least 95% of airborne particles
    • N99: filters at least 99% of airborne particles
    • N100: filters at least 99.97% of airborne particles

Respirator Trusted-Source Information

https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource.html

Conformity Assessment Notices and Letters to Manufacturers and Interested Parties

https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/default.html

Counterfeit Respirators / Misrepresentation of NIOSH-Approval

https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html

Additional Tips for Spotting Counterfeit Respirators

https://www.cdc.gov/niosh/npptl/usernotices/AdditionalTips.html

Face Masks and Surgical Masks for COVID-19: Manufacturing ...

Surgical Mask

Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/face-masks-and-surgical-masks-covid-19-manufacturing-purchasing-importing-and-donating-masks-during

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

codes for surgical masks (FXX, OUK, OXZ).

FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns-during-covid-19-pandemic

Emergency Use Authorization for Face Masks

https://www.fda.gov/media/137121/download

https://healthcentricadvisors.org/wp-content/uploads/2017/04/3_MaskEnomics_Poster_2012.pdf

https://www.halyardhealth.co.uk/media/17525789/hc342-02-uk_facialprotectionportfolio_2017.pdf

Green Reusable Surgical Gowns, For Hospital, Rs 250 /piece D & U ...

Medical Gowns

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns

American National Standards Institute/Association of the Advancement of Medical Instrumentation (ANSI/AAMI) PB70:2003

  1. Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
  2. Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
  3. Level 3: Moderate risk, to be used, for example, during arterial blood draw, inserting an Intravenous (IV) line, in the Emergency Room, or for trauma cases
  4. Level 4: High risk, to be used, for example, during long, fluid intense procedures, surgery,  when pathogen resistance is needed or infectious diseases are suspected (non-airborne)

Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.

The AAMI gown classification stems from four levels of barrier performance, measured accordingly with the following standardised tests:

  1. AATCC 42-2017: Measures resistance of fabrics to the penetration of water by impact (AATCC, 2018)
  2. AATCC 127-2017: Measures resistance of fabric to the penetration of water under hydrostatic pressure (AATCC, 2017)
  3. ASTM F1670-17: Evaluate resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact (ASTM, 2017)
  4. ASTM F1671-13: Measure penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact (ASTM, 2013)
Barrier PerformanceProtectionResistanceTestTest CriteriaAcceptable Quality
Level 1MinimalLiquid PenetrationAATCC42Water Impact ≤ 4.5g4%
Level 2LowLiquid PenetrationAATCC42
AATCC127
Spray Impact ≤ 1.0g
Hydrostatic Pressure ≥ 20cm
4%
4%
Level 3ModerateLiquid PenetrationAATCC42
AATCC127
Spray Impact ≤ 1.0g
Hydrostatic Pressure ≥ 50cm
4%
4%
Level 4HighLiquid and Viral PenetrationASTM F1671Pass4%

American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns:  tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission. 

Below is a summary of ASTM F2407 standard recognized by the FDA.

  • Tensile Strength: ASTM D5034, ASTM D1682
  • Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM  D1424
  • Seam Strength: ASTM D751 (stretch woven or knit)
  • Lint Generation (ISO 9073 Part 10)
  • Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75

Non-surgical gowns are Class I devices (exempt from premarket review) 

Use in low or minimal risk patient isolation situations & not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.

A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. 

Surgical gowns can be used for any risk level (Levels 1-4). 

All surgical gowns must be labeled as a surgical gown.

Surgical isolation gowns are used when there is a medium to high risk of contamination

Class II medical device that requires a 510(k) premarket notification. 

https://munglobal.com.au/resources/knowledge-base/personal-protective-equipment/aami-level-standards-for-gowns/

https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19)

https://www.fda.gov/media/136540/download

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

codes for gowns (FYA, FYB, FYC) 

Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care

https://www.fda.gov/media/95910/download

FAQs on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns-during-covid-19-pandemic

Other links

https://www.halyardhealth.com/media/538845/Guide-to-Gown-Guidelines.pdf

https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3

https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/cardinal-health-surgical-gowns-aami-level-3-educational-brochure.pdf

https://www.cardinalhealth.com/content/dam/corp/web/documents/brochure/cardinal-health-surgical-gowns-aami-level-4-educational-brochure.pdf

Medical Gloves

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves

Medical gloves are disposable and include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the FDA as Class I reserved medical devices that require a 510(k) premarket notification. FDA reviews these devices to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met.

510(k) Premarket Notification

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

Medical Glove Guidance Manual 

https://www.fda.gov/media/90612/download

Medical Gloves for COVID-19

https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gloves-covid-19

The FDA does not issue any kind of certification to demonstrate that a manufacturer is in compliance with the FDA’s requirements. The FDA recommends that manufacturers follow recognized standards for testing of gloves. You may consider asking for that information when purchasing gloves.

No, you do not need to apply to FDA for issuance of an Emergency Use Authorization (EUA) to import medical gloves.

Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19)

https://www.fda.gov/media/136540/download

Other PPE

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/personal-protective-equipment-infection-control

Other respirators Certified Equipment

https://www.cdc.gov/niosh/npptl/topics/respirators/cel/default.html

Odprawa celna dokumenty - Import z Chin odprawa celna
One is the official CE mark and the other is a CHINA EXPORT mark.

EU CE Regulation

Conformity assessment procedures for protective equipment

https://ec.europa.eu/docsroom/documents/40521

CE marking

https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

Information on CE marking and on the EC Declaration of Conformity based on testing services and certificates of the VDE Testing and Certification Institute

https://www2.vde.com/en/SiteCollectionDocuments/MCMS/VDE_PI/PDFs/PM92e.pdf

European standards for medical supplies made freely available to facilitate increase of production

https://ec.europa.eu/commission/presscorner/detail/en/IP_20_502

CE marking in your country

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

https://ec.europa.eu/growth/single-market/ce-marking/in-your-country/

CE Certificate Checklist 

If you answer ‘No’ to one or more of these questions, then contact your PPE suppliers immediately for advice.

  • Is the CE mark present on the product marking/labelling?
  • If present on the product, is the CE mark in the correct font and at least 5mm high?
  • For products, including respirators and chemical protective clothing, is the CE mark accompanied by a 4-digit number? (e.g. CE 0120)
  • Were written instructions for use provided within the product?
  • Are the instructions for use printed in the clear and legible text?
  • Is the name and address of the manufacturer detailed on the user instructions?
  • Does the certificate clearly contain the notified body’s name and number (4 digits)?
  • Is the notified body from within the EU? There are a few non-EU notified bodies and therefore caution should be taken?
  • Does the certificate show signs of tampering i.e. differing fonts and sizes, colour changes etc?
  • Does the certificate contain a date and notified body signature? (generally an individual)
  • Does the certificate have its terms and conditions included?
  • Does the certificate show a clear description of the product, including model references, specifications, and test references?
  • Does the certificate state that it is an EC type-examination certificate?
  • Does the certificate include a manufacturer’s name and address?
  • If a validity period is stated on the certificate, is it still current?

Safety Alerts
https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/?event=main.search&lng=en#searchResults

If you made it down here, then that’s it for now. I hope you just copy and paste it somewhere. Make it yours. Make it better. If you do make it better, then please show me your improved vetting list. Thank you. Stay safe.