US regulator pulls approval for dozens of companies making respirators in China
- The US Food and Drug Administration determined that many of the made-in-China N95-style masks filter out less than 95 per cent of particulate matter
- The approved number of manufacturers dropped to 14 from 86
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 per cent 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 respirators are key pieces of personal protective equipment used by health care providers on the front lines of the Covid-19 pandemic.
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“The FDA became aware that some of the respirators [authorised 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.