FDA Guidance on KN95 Masks


NCBFAA is hearing reports from brokers of delays and refusals by the U.S. Food and Drug Administration (FDA) of KN95 mask shipments. KN95 masks are an equivalent Chinese-alternative to the scarce N95 mask. We reached out to FDA and received the following reply which should help in getting clearance for these items:


FDA is using the CDC Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies information to expand access, which includes KN95s. Our Center for Devices is updating FDA’s website to indicate this, but the approach is in effect now. 


Our instructions on the entry process for KN95s and others are below:


KN95, KN100, KP100, and KP95 Filtering Facepiece Respirators (Standard GB 2626-2006) NOT Under EUA


CDC’s Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies identifies respirators approved under standards used in other countries that are similar to NIOSH-approved N95 respirators. CDC has determined these are suitable alternatives to provide protection during the COVID-19 response when supplies are short when they conform to standards identified and provide a protection factor of at least 10. FDA does not object to the importation and use of these respirators during the emergency.


FDA cannot confirm the performance and quality of face masks and respirators not under an EUA. The only person who can verify the authenticity is whoever issued it.


ACE Transmission Requirements for KN95s KN100, KP100, and KP95 NOT under EUA:


Program Code: DEV

Processing Code: NED

Intended Use Code: 940.000 if the product is listed on the CDC website

         081.001 if not listed on the CDC website

Product Code: 80N—ZJ

        Use the Product Classification and Product Code Builder

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