14
May
US Remove 74% of all Chinese N95 Mask Manufacturers from the FDA Approved List
On Friday 8th May, the US Food and Drug Administration (FDA) cut the approved list of Chinese vendors who make N95 masks to just 14, down for 86. The official reason for this is product failing to pass the required testing that each mask must adhere to. This means that there are now only 14 Chinese vendors who can legally ship N95 masks to the US.
Spot checks across the remaining approved supplier shipments are in place to ensure that the standard does not fall below the accepted level. Any supplier that has had their approval revoked can apply to have their products retested by the National Institute for Occupational Safety and Health (NIOSH) within 45 days. If they pass, they may be allowed back on the list and free to sell within the US. For more information on the FDA’s standards and testing requirements, please see here.
It is critical that all recommended masks, including N95, meet the stringent medical standards laid out by the FDA, otherwise wearers could be put at significant risk. For detailed information on the advised face masks for prevention against COVID19, please read our article here.
It is understandable that the US is protecting its citizens from unregulated masks, however, with their infection rate not yet slowing, there is an urgent need for more protective equipment by their frontline workers. Unfortunately, this move will likely cause an increase in pricing and expand lead times as these masks are now a far rarer commodity.
