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.
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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.
“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.
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 - or NIOSH] to determine whether the respirator meets the 95 per cent 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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The FDA’s crackdown partly reverses emergency measures it took last month to allow more imports of respirators made in China, many of which are known as KN95 masks, to meet demand as Covid-19 cases began to surge in the US, leaving supplies in the country’s hospitals short.
On April 3, the regulator issued an emergency use authorisaton for respirators from China that had not been NIOSH-approved, allowing imports from the larger list of 86 companies.
Under that order, companies could export the respirators to the US if they had regulatory authorization under a jurisdiction other than China that could be verified by FDA or could provide test reports from a recognized independent test laboratory that can be verified by the US regulator.
Manufacturers knocked off the FDA’s approved respirator list are eligible to get back on if they submit their products to testing by NIOSH within 45 days.
