These KN95 masks, manufactured in China, failed to demonstrate at least 95% particulate filtration efficiency in NIOSH testing, meaning they may not provide consistent and adequate respiratory protection.
The U.S. Food and Drug Administration has removed its Emergency Use Authorization (EUA) for several KN95 masks made in China after they failed to meet a minimum particulate filtration efficiency of 95% in National Institute for Occupational Safety and Health (NIOSH) testing.
The FDA had issued the EUA on April 3 for several makes and models of KN95 masks in response to mask shortages as a result of the COVID-19 pandemic. With this EUA, these masks were eligible for use as respirators if they met the necessary criteria.
The agency revised and reissued that authorization on May 7, however, after testing conducted by NIOSH found that the masks may not provide consistent and adequate respiratory protection from COVID-19.
Given the current public health emergency, the agency has authorized 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.
Among the KN95 masks that initially were authorized, and failed subsequent NIOSH testing are 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.
