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.
Related News Articles
Headline
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…
Headline
The Food and Drug Administration July 10 approved Moderna’s Spikevax COVID-19 vaccine for children under 12 with at least one underlying condition that…
Headline
The Occupational Safety and Health Administration June 30 released a proposed rule to remove what remains of its emergency temporary standard for occupational…
Headline
Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention…
Headline
Leaders of the Food and Drug Administration May 20 announced new guidelines for administering the COVID-19 vaccine in a paper published by the New England…
Headline
A study published April 8 by the Public Library of Science’s Journal of Global Public Health found that driving while infected with COVID-19 raises the risk of…