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Check Your Mask Inventory: FDA Revokes Authorization on Some KN95s


The United States Food and Drug Administration (FDA) recently revoked its emergency authorization of several KN95 masks because they could not meet the minimum particle filtration requirement of 95%. They include KN95 masks manufactured by the following companies:

  • 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

On April 3, the FDA initially gave emergency authorization to KN95s made by these companies, who had supplied testing results demonstrating their effectiveness, in response to a shortage caused by the COVID-19 pandemic. They were authorized for use as respirators, just like their N95 counterparts, which have been challenging to obtain. However, subsequent tests conducted by the National Institute for Occupational Safety and Health failed to demonstrate that these KN95s could meet the 95% filtration requirement. Read more here.

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