US FDA urgently authorizes a large number of Chinese KN95 masks to be exported, and 46 factories are authorized!

US FDA urgently authorizes a large number of Chinese KN95 masks to be exported, and 46 factories are authorized!

According to the real-time statistics system of global COVID-19 data released by Johns Hopkins University in the United States, as of 6 p.m. Eastern Time on April 13, a total of 570,000 confirmed cases of COVID-19, 23,000 deaths, and a total of 2.93 million tests have been reported in the United States.

 

The epidemic in the United States is still raging and escalating, and masks are still in short supply. The topic of masks in the United States is like a "blockbuster movie", with a dramatic plot twist every once in a while.

 




US FDA refuses entry of Chinese N95 masks


On March 17, the U.S. CDC released a "Strategy for Optimizing the Supply of N95 Respirators: Crisis/Alternative Strategy", approving that masks of the same level as N95 from other countries can be used as substitutes in the United States.

 

The list includes seven countries and regions, including Brazil, South Korea, Japan, Australia, Europe, Mexico and China (including four domestic mask models: KN100, KP100, KN95 and KP95).

 

But on March 28, the U.S. Food and Drug Administration (FDA) launched a new " Emergency-Use-Administration " (EUA), stating that there are only six countries and regions that can meet the specified performance standards for acceptable respirator products.

 

According to the Global Times, the US news website BuzzFeed reported on March 29 that "cases have surged and masks are in short supply, but the United States refuses China's KN95 masks." KN95 masks are China's alternative to N95 masks.

 

However, the U.S. Food and Drug Administration (FDA) refused to allow it to enter the U.S. The article questioned whether there were "political reasons" behind the FDA's decision.

 



On April 1, Chinese Foreign Ministry Spokesperson Hua Chunying said at a regular press conference that under the current epidemic situation, masks are urgently needed by all countries, and the demand in China is also very large. Chinese companies are working at full capacity, working overtime, and producing day and night to meet domestic demand while trying to provide protection for the prevention and control of the epidemic in various countries.

According to data released by the General Administration of Customs of China, from March 1 to April 4, the country approved the export of major epidemic prevention and control materials worth 10.2 billion yuan, mainly including about 3.86 billion masks worth 7.72 billion yuan, 37.52 million protective suits worth 910 million yuan, 2.41 million infrared thermometers worth 331 million yuan, 16,000 ventilators worth 310 million yuan, 2.84 million boxes of new coronavirus testing reagents, and 8.41 million pairs of goggles.





US FDA urgently authorizes 46 mask manufacturers in China



 

As the epidemic becomes more serious, the plot of the American mask blockbuster has taken another turn.

 

On April 11, US time, updated documents on the FDA (U.S. Food and Drug Administration) website showed that a total of 46 mask manufacturers with factories located in China have obtained emergency use authorization (EUA).

 

Except for foreign-funded enterprises such as 3M China and Creative Concepts, the rest of the companies are manufacturers across China , including Guangdong, Shandong, Henan, Sichuan, Jiangsu and other places. Among the companies that have obtained emergency authorization, 26 use China's KN95 standard to produce masks.

 

According to FDA documents, masks produced in China need to meet three requirements to obtain EUA authorization:


First, manufacturers with one or more NIOSH (National Institute for Occupational Safety and Health) certified products can verify other models of filtering facepiece respirators (FFRs) produced in accordance with applicable authorized standards in other countries/regions;


Second, if it is authorized in other regions outside of China, the FDA can verify it;


Third, there is a test report issued by an independent testing laboratory that can show that the product performance meets the applicable test criteria, which the FDA can verify.



 

 

 

Appendix: List of manufacturers authorized by FDA for emergency use

Source: SellerGrowth

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