FDA: Certain respirators from China no longer authorized for emergency use
The Food and Drug Administration yesterday revised its April 3 emergency use authorization for N95 and similar respirators made in China to remove certain respirators that failed to demonstrate at least 95% particulate filtration efficiency when tested by the National Institute for Occupational Safety and Health. Health care personnel should not use these respirators as personal protective equipment but may use them as face masks, FDA said. The unauthorized models are made 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.; and Lanshan Shendun Technology Co.
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