According to the document, the US Food and Drug Administration (FDA) has determined that many KN95 masks made in China are unqualified, and the number of particulate matter filtered by them is less than 95%, and the number of authorized manufacturers will be reduced from 86 to 14.
An FDA spokesman said in a statement: "Although the FDA continues to take actions to balance the urgent need for respirators for health care workers, we are also trying our best to ensure that health care workers are adequately protected." The statement also said that the agency will cooperate with CDC to increase the supply of masks and ensure their integrity.
N95 mask can prevent Covid-19 particles better than cloth mask or surgical mask, and it is in great demand among health care providers and emergency personnel. On April 3rd, there was a serious shortage of N95 masks, and the FDA allowed similar masks to be imported from China. The model of N95 in China was called KN95, and it was also required to filter 95% of particles above 0.3 micron, including Covid-19.
However, at that time, these imported masks (KN95) had not been tested by American regulators, but they had to be tested and sampled by an accredited laboratory to prove that they met the standards of the Centers for Disease Control and Prevention (CDC), that is, 95% of particles of 0.3 micron or larger, including Covid-19, were filtered.
However, the results of sampling inspection are worrying. Of the 11 masks that FDA authorized to be sold to American hospitals, 7 were unqualified. According to a test conducted by CDC on April 15th, one mask can only remove 24% to 35% of particles, while some masks have good detection results, such as those produced by DaddyBaby Company in Fuzhou, China, which is a diaper manufacturer. These masks can block 91% to 93.5% of particles.
Health institutions also tested some KN95 masks that were not approved by the institutions. The FDA said that one of them can only block about 1% of the particles, which is irritating!
In the end, although CDC only tested about 10 allowed masks, FDA removed all other untested masks from the list and gave their manufacturers 45 days to resume testing.
Companies that have the right to export China-made "filter masks and respirators" include 3M in Minnesota and BYD in Shenzhen, which makes electric buses in California. And won a $1 billion mask contract from the California government. However, due to the failure to obtain FDA certification before the deadline of April 30, BYD will refund half of the advance payment paid by the state for a mask contract worth about $1 billion, that is, $247 million.
According to a contract revised on Wednesday, the deadline for BYD’s masks to obtain federal certification will be postponed to May 31, and if it cannot be certified by then, BYD will refund the other half of the advance payment, the California Emergency Office said.
In other words, if BYD does not get the FDA certification by May 31st, it will lose more than $500 million.
The FDA also said that it is strengthening the monitoring and sampling of all imported respirators, and all respirators imported from the United States will be randomly sampled and tested by (American Institute of Occupational Safety and Health) to ensure that respirators meet 95% particle filtration standards.