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 — PPE Connector
PLEASE NOTE: This article is being constantly updated as I receive new, accurate information about this on-going problem. Also, we have started two new websites:
KN95RespiratorMasksForSale.com: Group Buy deal for respirators, authentic PPE due to direct buy from factories in China (GROUPON for PPE).
PPEConnector.com: first online, open marketplace for qualified suppliers and end-users of authentic PPE
PPECertification.com: PPE background check and fraud alerts.
People ask me about my vetting process and my knowledge sources because I have been vetting non-traditional suppliers and non-FDA authorized PPE since March of 2020 for an NGO. 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
- OPEN PPE Marketplace for sellers and buyers: PPEConnector.com
How to evaluate vendors, manufacturers, and suppliers
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
- Name: First and Last
- Email: (business email — NO Yahoo, Gmail, Outlook, AOL, Hotmail, iCloud, @163, @126, @qq, @sina, etc…)
- Business name:
- Address:
- Phone:
- Linkedin:
- Website:
- Sales catalog
- Price list — FOB and CIF shipping terms
- Quantity of stock available
- Amount of production capacity available
- Shipping time
- Payment terms
- Include all certificates and photos
- Factory and Produce level certification
- Up to the last 3 shipments or deals with end-users (hospitals, government, NGO):
- Standard Operating Procedure & Terms
- Proof FDA registered manufacturer
- History of company: How long manufacturing products
- Do you offer samples?
How to evaluate for Third-Party participants
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.
- Financial strength of intermediary: financial statement, balance sheet
- History with other end-users
- Contract: provision to protect purchase if product authenticity or quality issue: manufacturer and third party financially guarantee if issues
How to evaluate 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
How to evaluate NIOSH-approved 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
How to evaluate non-NIOSH approved respirators under the EUA
FAQs on the EUAs for Non-NIOSH Approved Respirators During the 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)
Additional CDC guidelines
https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/international-respirator-purchase.html
- ISO/IEC 17025 accredited test laboratory
- Certified labs for testing masks in China:
- https://economie.fgov.be/sites/default/files/Files/Entreprises/laboratories-accredited-by-cnas-for-testing-of-maks.pdf
- https://las.cnas.org.cn/LAS_FQ/publish/externalQueryL1En.jsp
- Certified labs for testing masks in Europe:
- https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=155501
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
How to evaluate Surgical Masks
- The surgical masks meets liquid barrier performance consistent with ASTM F1862 standard
- https://www.astm.org/Standards/F1862.htm
- https://www.astm.org/standardization-news/?q=features/standards-medical-face-masks-and-protective-clothing-.html
- Disclaimer and the Class I or Class II flammability requirement per 16 CFR Part 1610 (unless labeled with a recommendation against use in the presence of high intensity heath source or flammable gas);
- https://www.govinfo.gov/app/details/CFR-2016-title16-vol2/CFR-2016-title16-vol2-part1610
- The surgical masks include labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which do not include any drugs or biologics); and
- The surgical masks are not intended for any use that would create such an undue risk. For example, the labeling does not include uses for antimicrobial or antiviral protection, infection prevention or reduction, or related uses, and does not include particulate filtration claims.
Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency
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
Emergency Use Authorization for Face Masks
https://www.fda.gov/media/137121/download
https://www.halyardhealth.co.uk/media/17525789/hc342-02-uk_facialprotectionportfolio_2017.pdf
How to evaluate 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
- Level 1: Minimal risk, to be used, for example, during basic care, standard isolation, cover gown for visitors, or in a standard medical unit
- Level 2: Low risk, to be used, for example, during blood draw, suturing, in the Intensive Care Unit (ICU), or a pathology lab
- 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
- 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:
- AATCC 42–2017: Measures resistance of fabrics to the penetration of water by impact (AATCC, 2018)
- AATCC 127–2017: Measures resistance of fabric to the penetration of water under hydrostatic pressure (AATCC, 2017)
- ASTM F1670–17: Evaluate resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact (ASTM, 2017)
- ASTM F1671–13: Measure penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact (ASTM, 2013)
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://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
Other links
https://www.halyardhealth.com/media/538845/Guide-to-Gown-Guidelines.pdf
https://wwwn.cdc.gov/PPEInfo/Standards/Info/ANSI/AAMIPB70Class3
How to evaluate 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
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
How to evaluate other PPE
Other respirators Certified Equipment https://www.cdc.gov/niosh/npptl/topics/respirators/cel/default.html
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.
KN95RespiratorMasksForSale.com: Group Buy deal for respirators, authentic PPE due to direct buy from factories in China (GROUPON for PPE).
PPEConnector.com: first online, open marketplace for qualified suppliers and end-users of authentic PPE
PPECertification.com: PPE background check and fraud alerts.
Originally published at https://ppeconnector.com on May 27, 2020.
