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FDA removes Emergency Use Authorization for some KN95 masks

Masks failed to demonstrate at least 95% particulate filtration efficiency

May 15, 2020

By Mary Beth Versaci

The U.S. Food and Drug Administration has removed its Emergency Use Authorization 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.

During a public health emergency, the FDA can authorize the use of medical products that have not gone through the regular approval process, as well as the off-label use of medical products that previously were approved for other uses. The FDA can grant Emergency Use Authorization for devices or medications used to diagnose, treat or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved and available alternatives, according to its website.

In response to continued mask shortages, the FDA issued an Emergency Use Authorization on April 3 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. The testing had been performed by recognized independent test laboratories.

Some KN95 masks that initially were authorized failed subsequent National Institute for Occupational Safety and Health testing and cannot be relied upon as respirators. These include masks manufactured by:

• CTT Co. Ltd.
• Daddybaby Co. Ltd.
• Dongguan Xianda Medical Equipment Co. Ltd.
• Guangdong Fei Fan Mstar Technology Ltd.
• Guangdong Nuokang Medical Technology Co. Ltd.
• Huizhou Huinuo Technology Co. Ltd.
• Lanshan Shendun Technology Co.

The remaining KN95 masks that demonstrated at least 95% filtration efficiency remain authorized for emergency use as respirators.

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. The CDC also has a form on its National Personal Protective Technology Laboratory webpage to request that an international mask be tested.