"Respirators that no longer appear in Appendix A may not reliably provide a minimum percent particulate filtration efficiency of 95 percent," the release said. "Among products removed from Appendix A to date, the following failed to demonstrate a minimum percent particulate filtration efficiency of 95 percent in testing conducted by NIOSH [National Institute for Occupational Safety and Health]."
Appendix A refers to a list of N95 masks granted emergency use authorization by the FDA in a 7 May notice.
The FDA decertified respirator masks from the following Chinese companies: CTT Co.; Daddybaby Co; Dongguan Xianda Medical Equipment Co.; Guangdong Fei Fan Mstar Technology; Guangdong Nuokang Medical Technology Co.; Huizhou Huinuo Technology Co.; and Lanshan Shendun Technology Co., the release said.
Apart from the United States, several European nations have returned Chinese-made COVID-19 supplies, including masks, gowns and testing supplies that proved defective, according to media reports.
The defective N95 masks can still be used as if they were standard surgical masks, which prevent an infected person from spreading the disease to others but do not protect the user from becoming infected.
Unlike surgical masks, N95 respirator masks include a filter that is intended to protect the user from catching the disease.
