The US Food and Drug Administration (FDA) said on Thursday (7th) that it found that the imported N95 masks were far below the standard, and the quality was poor, and announced that it had withdrawn more than 60 Chinese manufacturers’ permission to export N95 masks to the United States. Officials at the US Centers for Disease Control and Prevention (CDC) have criticized that some masks are far below the standard.
The National Institute for Occupational Safety and Health (NIOSH) under the US Centers for Disease Control and Prevention (NIOSH) previously inspected 67 KN95 masks produced by Chinese manufacturers. 60% of the particle filter efficiency tests failed. Some Chinese masks only filtered 24% to 35% of the particulate matter is far below the 95% filtering standard required by the naming of N95 masks.
The FDA announced at the beginning of last month that foreign manufacturers are allowed to export masks to the United States without testing by the US authorities as long as they meet other national standards or are subject to independent laboratory review and approval. The FDA overturned its decision on Thursday due to the quality of imported masks.
Currently, only masks are allowed to be imported from certified manufacturers outside the United States or the European Union and other regions in China. The number of licensed N95 mask manufacturers in China was reduced from about 80 to 14.