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FDA Removes Emergency Use Authorization For Several KN95 Masks

Face Masks and Surgical Masks for COVID-19: Manufacturing ...
The ADA News (5/15, Versaci) reports, “The U.S. Food and Drug Administration has removed its Emergency Use Authorization [EUA] for several KN95 masks, which are made in China, after they failed to meet a minimum particulate filtration efficiency of 95% in National Institute for Occupational Safety and Health testing.” The article notes that on April 3 the FDA issued an EUA “for several makes and models of KN95 masks, making them eligible for use as respirators if they met the necessary criteria.” However, “the agency revised and reissued the authorization on May 7 because of concerns about the authenticity of masks that were approved for use based on test reports submitted to the FDA by the manufacturer or importer of the masks.”

For a full list of personal protective equipment authorized for emergency use by the FDA, go to the agency’s Emergency Use Authorizations webpage.

To learn more about factors to consider when purchasing masks from another country, including KN95 masks, visit the Centers for Disease Control and Prevention website.