'95% filtration claimed, only 24%' US FDA bans massive imports of Chinese masks

Crackdown on 67 Chinese Mask Companies
Using FDA Mark Without Approval

[Asia Economy New York=Correspondent Baek Jong-min] The U.S. Food and Drug Administration (FDA) has revoked approvals for a large number of Chinese-made masks, the Wall Street Journal (WSJ) reported on the 7th (local time). This move is interpreted as a swift response to growing complaints about defective Chinese masks.

According to WSJ, the FDA withdrew export approvals for 'N95' grade masks manufactured by 66 Chinese companies. As a result, the number of Chinese manufacturers authorized to import 'N95' grade masks into the U.S. has been reduced from 80 to 14.

[Image source=Yonhap News]

Earlier, as the mask shortage worsened, the FDA temporarily allowed the import of Chinese masks that had not completed performance testing on the 3rd of last month, and has since been conducting tests on these masks through independent laboratories.

Currently, as it has become difficult to obtain 'N95' grade masks made by U.S. companies domestically, 'KN95' grade masks certified by China as 'N95' grade are being widely distributed.

Inspection results from the National Institute for Occupational Safety and Health showed that some Chinese masks filtered only 24% to 35% of particles. This performance is far from that of 'N95' grade masks, which must filter 95% of particles. Some even misled consumers by affixing the FDA mark, which had not been approved, on the packaging.

An FDA official explained the recent action by saying, "As mask supply increased, masks that did not meet performance standards also increased."

Mask issues are a critical point for the resumption of economic activities in the U.S., to the extent that President Donald Trump visited the Honeywell mask manufacturing plant on the 5th to inspect production status. Nevertheless, concerns are growing as substandard Chinese products continue to spread in the market.

A representative from the Centers for Disease Control and Prevention (CDC) also pointed out, "Some masks seriously failed to meet standards."

This content was produced with the assistance of AI translation services.