The US administration has identified many N95 masks made in China capable of filtering fine particles of less than 95%, cutting the number of approved manufacturers from 86 to 14.
The US Food and Drug Administration (FDA) on Tuesday halted licensing for dozens of companies that manufacture industrial-grade masks in China, citing quality reasons. The FDA also warns health care providers to reconsider using any of the “blacklist” products.
After the FDA determined that many N95 masks made in China were capable of filtering fine particles of less than 95% – the standard that led to the name “N95” – the number of approved manufacturers decreased from 86 to 14. , South China Morning Post said.
Companies that hold the right to export “filterable specialized masks” made in China to the US include 3M company based in Minnesota of the US and BYD company based in Shenzhen, China. Quoc.
Specialized masks are the key personal protective equipment used by medical personnel on the front line of the Covid-19 epidemic.
“The FDA is aware that some specialized facemasks [licensed in previous FDA guidelines] have not been as effective as expected (despite sending the test report to the FDA). This means that these samples allow more small particles to pass than the quality standards listed on their labels, “the FDA said.
The FDA is “strengthening surveillance and sampling of all kinds of specialized masks imported from China – every shipment of masks from China to the US will have to be randomly sampled and tested by the [Institute of Safety and Occupational Health – NIOSH] to determine whether a respirator meets the fine particulate filtration standard up to 95%. “
Special masks from China that are not on the approved manufacturers list can still be used as normal masks. This group, more broadly defined, includes the types of medical masks used to “control the source of infection”, which help limit the spread of the virus when the wearer speaks, coughs or sneezes.
The FDA decision partially reversed the emergency measures it took last month to allow the import of more masks made in China, many of which are called KN95 masks, to meet demand. when the number of Covid-19 cases began to increase sharply in the United States.
On April 3, the FDA allowed emergency use of specialized masks from China that have not been approved by NIOSH, agreeing to import goods from 86 companies on the list.