N95/KN95 Verification Guidelines
Purpose:
This document is only a guide to provide a basic due diligence toolkit for gathering relevant background on suppliers/vendors selling personal protective equipment (PPE).
How to Use This Document:
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This document contains links to verify factories of origin and products with the United States FDA (Food and Drug Administration) and the CDC (Centers for Disease Control).
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It also lists standard categories of information you should expect to receive from suppliers or factories.
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In the vast majority of cases, most fraudulent sellers will not be able to provide you with this information. A sophisticated few will counterfeit legitimate documents and present it as valid.
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This was written for sourcing N95s.However, it can be applied to guide the overall approach to KN95s and other PPE.
How NOT to Use This Document:
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This document is not an instruction manual or a checklist for authenticating PPE. That can only be done by industry professionals and validated by a lab filtration test
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This is not a fully comprehensive or foolproof checklist. Checking information against the FDA and NIOSH (National Institute for Occupational Safety and Health) registries will give a higher degree of confidence that the factories and products presented to you are legitimate
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It is NOT a guarantee the products being offered are authentic
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Counterfeiting is rampant. Buyer beware!
Helpful documents to guide you:
Get Up-to-date
Please acquaint yourself with the following guidance from the FDA and the CDC.
LEVEL 1 CRITERIA
FDA/CDC Verification
NIOSH N95 respirators, check potential vendor/supplier information against the following four sites first:
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FDA Establishment Registration & Device Listing. Approved manufacturers and/or products are listed here.
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21 CFR 878.4040 | Surgical N95 Respirators are product code MSH and ONT.
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21 CFR 880.6260 | N95 Respirators are product code NZJ and ORW.
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National Personal Protective Technology Laboratory site. The CDC-approved manufacturers of N95 respirators are listed here.
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NIOSH Certified equipment list. The CDC-approved N95 respirators are listed here.
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CDC counterfeit list (not comprehensive). Known fraudulent products and brands appear here.
KN95 respirators (China), check potential vendor information against the following sites first:
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FDA Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China.
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FDA Establishment Registration & Device Listing. Approved manufacturers and/or products are listed here.
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21 CFR 880.6260 | N95 Respirators are product code NZJ and ORW.
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LEVEL 2 CRITERIA
Supplier Verification
Validate information given to you.
All legitimate vendors/suppliers should be able to provide the following answers and documentation:
Information From Potential Vendor/Supplier:
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Business Registered Name AND Trading Name (Chinese & English)/Website/Contact Info for Principals/Sales.
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Sales Catalog (6 PPE product categories specifically).
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Current Pricing List Inclusive of Shipping via Air Freight with SKU Descriptions.
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All Factory & Product level certifications (e.g. FDA, CE, NIOSH/CDC).
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For N95/KN95 PPE: Filtration efficiency test reports.
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Commercial Bank References.
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Current Medical & Healthcare Accounts as business references & W9 Statements.
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Sales / Distributor, Import / Export partners.
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Photos and Video of their factory floor, clear photos of products and packaging, (short video of products are best).
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Typical total production output per week/month, by SKU.
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Order quantity to be considered for capacity allocation (one time vs. rolling basis).
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Number of items per box, boxes per pallet and weight (kg/lbs).
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Closest commercial airport, Transport info for freight and logistics.
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Sales process/Terms and conditions/Warranties.
Note: Answering these questions is not a guarantee of product authenticity. Once the product leaves the factory, it is virtually impossible for intermediaries to authenticate the efficacy of products, products’ functional claims or ratings, standards, or certifications.
Red
Flags
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Providing certificates. The FDA and the CDC do not issue certificates. These agencies write letters with assigned code numbers that can be checked on the agencies’ respective websites. Certificates are distractions—check the numbers
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The factory is unable to provide Level 1 documentation. All legitimate certified factories are accustomed to providing this
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A factory is unable, or unwilling, to give concrete numbers about production over a period of time
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Artificially high prices are supported by misinformed buyers. By everyone choosing not to pay inflated prices collectively, we can remove incentives for price gouging and eliminate a significant portion of the bad actors by not buying from them
