The U.S. Food and Drug Administration FDA urgently approved non-N95 masks that have been certified by five countries and the European Union, but China’s KN95 masks are not on the list, which means that China’s KN95 standard masks are no longer authorized to use.
If there is no FDA’s Approved, US importers dare not rush to order Chinese KN95 masks because they fear that they will be seized by customs. U.S. hospitals will refuse to accept KN95 mask donations because they are worried that if medical staff have health problems when using unauthorized equipment, the hospital will bear legal responsibility.
Then why the number of confirmed cases in the United States soars to 220,000 No, the anti-epidemic supplies are so tight that even if they bear the risk of infection, they still refuse to accept the Chinese standard KN95 masks?
N95 is the certification level of American respirators, certified by the National Institute of Occupational Safety and Health (NIOSH). This type of mask can filter out more than 95% of non-oily particles (aerosol) under the specified air flow (85L/min), so it is named N95. And if it can filter more than 99% of particulate matter (aerosol), it is called N99 mask.
Corresponding to N95, KN95 is a respirator certified by the Chinese GB2626-2006 Respiratory Protective Equipment Self-priming Filter Type Anti-Particulate Respirator Standard. The test conditions of the product are completely consistent with the US N95 standard.
Regarding the US requirement, We must have a clear and sober understanding that the United States is not rejecting Chinese masks, but rejecting KN95 masks produced according to Chinese standards. It is not an FDA-certified N95 mask under the authorization of NIOSH of the United States.
Masks sold in China, no matter it is KN95 is still a disposable mask for civilian use. Regardless of whether there is this epidemic or not, it is almost unregulated for so many years. The lack of evidence and credibility certification can show that he can meet the KN95 standard. The public does not have any ability to identify, and there is no organization that can help you identify.