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Originally published as Unreliable! The practice of KN95 standard masks before and after FDA in the United States is worth tasting carefully! Recently, in less than two weeks, the US policy on Chinese-made masks has been completely reversed, from acceptance to rejection. Guide to the main points In the new emergency use authorization (EUA) list of disposable respirators issued by FDA, China's KN95 protective products were cancelled; The CDC considers KN95 masks to be one of many "suitable alternatives" to N95 mask that are in short supply; The cancellation of China's KN95 import by the United States will further increase the risk of infection among health care workers. According to foreign media reports, the United States is facing a shortage of N95 mask, KN95 masks from China are considered an alternative to N95 mask, but the FDA has refused to import Chinese KN95 masks. FDA Excludes KN95 Masks From Approved Import List According to U.S. law, most medical devices, including masks, must be licensed by the U.S. Food and Drug Administration (FDA) before they can be imported into or sold in the United States. Not long ago, on March 17, the Centers for Disease Control and Prevention (CDC) of the United States issued "Strategies for Optimizing the Supply of N95 mask: Crisis/Alternative Strategies", pointing out that during the COVID-19 pandemic, when the supply of N95 mask is insufficient, masks produced according to the standards in the following table are suitable substitutes for N95 mask. The list includes Brazil,Full Body Disposable Coverall, South Korea, Japan, Australia, Europe, Mexico and China (including four domestic mask models: KN100, KP100, KN95,KN95 Face Mask, KP95), a total of seven countries and regions. These include masks produced according to Chinese standards GB 2626-2006 and GB/T 18664-2002. But on March 28, the FDA launched a new "Emergency-Use-Administration" (EUA), which approved the non- N95 mask certified by five countries and the European Union. China's KN95 masks are not on the list. China is the only one missing! This means that other people's masks can be sold to the United States as long as they meet the N95 standard of their own country or region, but not in China. Chinese masks must meet the NOISH-N95 standard and certification before they can be used in the United States! Expand the full text FDA approved imports of non-N95 mask certified by Australia, Brazil, Japan, South Korea, Mexico and the European Union, but did not approve KN95 masks produced in China. Originally, during the epidemic period, KN95 Mask with Fast Shipping ,Quickly Delivery Disposable Protective Clothing, importers were required to apply to the FDA for the emergency use qualification of masks to enter the U.S. market, but in this list, the original FDA registration process and NIOSH testing process can be simplified and put into use quickly. But! The US FDA announced that China's KN95 standard masks will no longer be authorized for use from March 28! That is to say, if you sell Chinese standard masks again, the United States may punish you in the future. When the supply of masks and ventilators in the United States was in short supply, the FDA announced that Chinese standard masks could be used. In the past two days, the United States found 39 million masks, 10 million masks, ventilators and so on. The medical protective materials in the United States were not so scarce, so they burned the bridge again! And it's only China that's been deauthorized!!! CDC: KN95 Is a Suitable Alternative to N95 Previously, after rigorous testing, the CDC recognized China's mask standards and technological standards, and said that KN95 masks were one of many "suitable alternatives" for N95 mask in short supply. However, the KN95 complies with slightly different specifications than the N95 and is not certified by the U.S. government. It is understood that KN95 masks have a filtration rate of at least 95% for non-oily particles with a size of 0.3 microns or larger, which has the same effect as N95. KN95 protective mask produced by 3m.
Most of the protective masks, including N95 and KN95, are made in China. Export restrictions have eased as the epidemic in China has slowed, but even if the United States agrees to import, it will have to "snap up" along with dozens of other countries in urgent need of masks. Allowing the import and use of KN95 will greatly alleviate the shortage of masks in the United States, but without FDA approval, importers will not dare to order KN95 masks rashly because they are afraid of being detained by customs. Similarly, many hospitals refuse to accept donations of KN95 masks because they fear that hospitals will be held legally responsible if health care workers have health problems when using unauthorized equipment. Usually, N95 mask in the United States are in sufficient supply, and are sold in major pharmacies for about $1 each, with wholesale prices as low as 35 cents. But in just two months, the outbreak of the epidemic has led to a shortage of supply, and the price of N95 mask has risen to $12 or more. At the same time, the network is also full of false transactions or counterfeit products, which further makes medical staff face a more serious risk of infection. At the same time, according to industry sources, the production capacity of newly approved masks from Australia, Brazil, Japan, South Korea, Mexico and the European Union in the United States is far less than that of N95 or KN95. The FDA's decision has aroused many doubts from the outside world, but at present the FDA has not made any comments on the doubts of the outside world. This article was compiled from the buzzfeednew website. The content of the article is for reference only. Source | CPRJ Plastic Rubber Box News Technology Sub-----ion Number Whale Transport Baby GUESSER, Editor | Testing WeChat Platform ID: testbbs Declarations: 1. Part of the graphic information comes from the Internet, and the copyright belongs to the original author. If there is any infringement,Antivirus Disposable Mask with CE Certificate, it shall be informed in time and deleted after verification; 2. The information content is only for learning and reference, and does not guarantee the accuracy, reliability or completeness of the information; return to Sohu to see more Responsible Editor:. zjyuan-group.com |
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