FDA rescinds emergency use authorization for several KN95 masks

The FDA removed its emergency use authorization for some KN95 masks made in China after they failed to meet a filtration efficiency rate of 95 percent during testing by the National Institute for Occupational Safety and Health.

In response to the pandemic-induced mask shortages, the FDA on April 3 authorized emergency use of several models of KN95 masks that had not gone through the standard approval process. The agency edited and reissued the authorization May 7 based on concerns about the masks' effectiveness brought to light by safety testing and reports submitted by the manufacturer or importer of the masks.

The KN95 masks that were initially authorized for emergency use but failed subsequent safety testing include those 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.

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