Breaking news! The United States suddenly canceled its approval of China's KN95 mask standards!

The U.S. Food and Drug Administration (FDA) has launched a new "Emergency-Use-Administration" (EUA), stating that there are only six countries and regions with acceptable mask standards that can meet the specified performance standards. The Chinese mask standard that was recognized two weeks ago has disappeared from the list!　　

The US FDA has updated the emergency use authorization EUA for Non-NIOSH approved masks. In this published document, it is clearly mentioned that respirator products provided by other countries have been evaluated using some methods similar to those of NIOSH. According to the guidance issued by the US FDA, China's KN95 masks are no longer approved for use in the United States. The guidance excludes China from the list of Non-NIOSH countries. Masks made in China, including KN95, KP100, KN100 and KP95, will not be included in the EUA list.

Two weeks ago, on March 17, the U.S. Centers for Disease Control and Prevention (CDC) announced the "Strategy for Optimizing the Supply of N95 Respirators: Crisis/Alternative Strategies", 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: Brazil, South Korea, Japan, Australia, Europe, Mexico and China (including four domestic mask models: KN100, KP100, KN95, KP95) . Why did the FDA, which had previously claimed to accept China's mask standards, disappear in an official notice just two weeks later? Moreover, comparing the two notices, China is the only country missing from the list of seven countries outside the United States whose standards are to be recognized!

Previously, after rigorous testing, the U.S. Centers for Disease Control and Prevention (CDC) recognized China's mask standards and workmanship, and stated that KN95 masks are one of many "suitable alternatives" to the N95 masks that are in short supply. However, the specifications followed by KN95 are slightly different from those of N95 and have not been certified by the U.S. government.

It is understood that the filtration rate of KN95 masks for non-oily particles with a size of 0.3 microns or larger is at least 95%, which is the same effect as N95. Allowing the import and use of KN95 will greatly alleviate the shortage of masks in the United States, but without FDA approval, importers dare not rashly order KN95 masks because they are worried that they will be seized by customs. According to industry insiders, the production capacity of masks newly approved by the United States from Australia, Brazil, Japan, South Korea, Mexico and the European Union is far less than that of N95 or KN95. This decision of the FDA has caused a lot of doubts from the outside world, but the FDA has not made any comments on the doubts of the outside world.

According to the announcement, when NIOSH became aware of counterfeit masks or masks that misrepresented NIOSH-approved masks on the market, the US CDC released a list of false masks to alert users, buyers and manufacturers.　　

These are examples of counterfeit masks. The Ironwear filtering facepiece respirators, model numbers 1505 and 1510, are not NIOSH approved. (2020/3/19)　　　　

This is a false representation of NIOSH approval. Yark is not a NIOSH approval holder nor a private label holder. Additionally, the mask inside the box includes the CE (European) certification mark and a NIOSH N95. This is not acceptable for a NIOSH approved mask. (March 5, 2020)

So, how do exporters identify NIOSH-approved filtering masks? The CDC has made the following picture demonstration, and everyone can look at these appearance marks when purchasing in the future.　

According to the above FDA requirements, only masks that meet the N95 level standards of the corresponding country or region can be sold to the United States. Masks of Chinese standard KN95 and other models must meet the NOISH-N95 standards and certifications before they can be used in the United States.

Previously, when the mask standards were relaxed, many netizens reminded that export companies selling masks in the United States should be careful about legal risks due to quality issues and be held accountable by the United States later.

Source: SellerGrowth