KN95 masks allowed from China

The KN95 is described as a Chinese version of the N95 mask, which US medical staff use to protect themselves from airborne bacteria and viruses, the report said. However, while KN95 masks can be imported, the product has not been approved by the FDA, which means that those who use them are not protected by law.

The CDC has listed KN95 as an ***native to other approved masks in case of emergency, but the FDA has not authorized the chinese-made KN95 under the emergency use license.

FDA officials told the The Hill, "The FDA generally does not object to the import and use of KN95 masks without EUA authorization. Although not required, if the KN95 mask does not have EUA, the importer may wish to take appropriate steps to verify the authenticity of these products. FDA stands ready to engage with importers to minimize interference during the import process."

 The FDA previously announced that it would relax regulations on face masks, but did not specifically mention KN95. The FDA said in a statement, "Recently, the FDA issued Eua, which can help increase the supply of filter masks by authorizing the use of certain imported disposable respirators for health care professionals without the approval of Niosh, the National Institute of Occupational Safety and health. We will continue to explore strategies to increase the availability of these devices."

The agency also said it is working with manufacturers to produce masks as demand from health care workers and the public increases. "We are providing as much regulatory flexibility as possible, " the FDA statement added, as the agency allowed imports of KN95 masks from China, some Republican lawmakers have expressed concern about America's dependence on China for medical supplies and various medicines. China's KN95 mask is a replacement for the N95 mask, but the U.S. food and Drug Administration has refused to allow it into the United States, BuzzFeed reported on March 29. On March 28th, to ease a national shortage of medical and protective equipment, the FDA approved non-N95 masks approved by the European Union and five countries (Australia, Brazil, Japan, South Korea and Mexico) , but KN95 masks did not receive emergency authorization.

At a regular press conference at the Ministry of Foreign Affairs on April 1, Foreign Ministry spokesman Hua Chunying said in response to a question: "The U.S. FDA has refused to allow KN95 masks into the United States. Can China confirm and comment on this? " "I've seen the reports. I don't know the details. If the report is true, I do not know what the United States is considering to make this decision. All I can say is that under the current epidemic situation, masks are urgently needed by all countries, and China's domestic demand is also great. Chinese enterprises are working at full capacity, working overtime and day and night to meet domestic demand while trying to provide safeguards for the prevention and control of the epidemic in all countries. Indeed, the supply of anti-epidemic materials also involves specific issues such as differences in certification standards for products in diffezrent countries and regions. But these issues should not be an obstacle to co-operation in fighting the epidemic."