A US regulator on Thursday pulled approval for dozens of companies making industry-standard masks in China, citing substandard performance, and warned health care providers to reconsider using any of the now-blacklisted products.
After the US Food and Drug Administration’s determination that many of the made-in-China N95-style masks filter out less than 95% of particulate matter the filtration level that gives the N95 mask its name the approved number of manufacturers dropped to 14 from 86, according to FDA documentation.
Companies retaining the right to export Chinese-made filtering facepiece respirators to the US include Minnesota-based company 3M and Shenzhen, China-based BYD, which produces battery-powered buses in California.
The FDA became aware that some of the respirators authorized in earlier FDA guidance failed to meet the expected performance (despite submitting passing test report results to the FDA), which means that these sampled products allowed more tiny particles than their labeled performance standard permits, the regulator said in an email.
The FDA is increasing surveillance and sampling of all respirators imported from China all respirator shipments from China that come into the US will be subject to random sampling and testing by the National Institute for Occupational Safety and Health to determine whether the respirator meets the 95% particulate filtration standard, the regulator said.
Chinese-made respirators not on the list of approved manufacturers can still be used as general face masks, a broader category that includes the more loose-fitting surgical masks for source control, to help inhibit the spread of infection when the wearer speaks, coughs or sneezes.
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