FDA Reverses Course, Approves China’s Equivalent Of The N95 Mask To Protect Against Coronavirus


Topline: The Food and Drug Administration on Friday approved a Chinese-made particle-blocking mask for use during the coronavirus pandemic, reversing course after weeks of pleas from healthcare workers who report dire shortages of masks and other personal protective equipment at hospitals across the country.

  • The FDA added the KN95 mask, the Chinese equivalent of an N95 mask, to the list of authorized gear to combat the coronavirus through an Emergency Use Authorization.
  • The KN95 still creates a seal around a wearer’s mouth to block dangerous particles, but it was manufactured under slightly different regulatory and testing standards than N95 masks.
  • In response to severe shortages of protective gear, the FDA approved respirator masks from Australia, Brazil, Europe, Japan, Korea and Mexico on March 24, but notably left off KN95 masks from China over concerns about fraudulent products.
  • Before KN95s were approved, the rules surrounding them caused confusion among mask sellers. The Centers for Disease Control list them as an appropriate alternative to N95s, but the FDA had not approved them.
  • KN95 masks are cheaper and more readily available than N95 masks, said Michael Brugger, the president of Fully Promoted, a company selling masks and other gear for healthcare workers, who added that because of confusion before the FDA approval, he had orders of KN95s bound for the U.S. stuck in customs in China.
  • The agency said KN95 masks will only be eligible for authorization if there is “evidence demonstrating that the respirator is authentic.”
  • As of Friday, the FDA only approved KN95 masks made by one Chinese company, BYD Precision Manufacture, which said in mid-March it could produce 5 million masks per day. 

Key background: Healthcare workers, along with state and local officials, have been sounding the alarm over a dangerous shortage of essential equipment protecting nurses and doctors on the frontlines, such as masks, gowns and gloves. The situation has gotten so dire that healthcare workers in New York are reusing masks only meant for a single use. As a result, the mask market has been thrown into chaos, with prices continuing to increase as countries and U.S. states battle for the same limited supply.

News peg: The U.S. is experiencing the worst outbreak of the coronavirus in the world with more than 266,000 cases. Public health officials have said the peak in cases will hit next week. Democratic governors in some states have criticized President Donald Trump for not doing enough to ensure they have enough masks and other gear for healthcare workers. Trump has lashed out at mask manufacturer 3M for not selling enough masks to those in the U.S. who need them, and on Thursday, the Trump administration invoked the Defense Production Act to force the company to prioritize orders from the U.S. 


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