"After facing criticism for its policies that limited the availability of critically needed face masks, the Food and Drug Administration (FDA) now says it will allow KN95 masks to be bought by hospitals and used by health care workers.
The KN95 designation is a Chinese government standard that is widely considered to be equivalent to the N95 masks approved by American regulators. Guidance issued by the Centers for Disease Control (CDC) says the KN95 masks are "suitable alternatives" to the N95 mask when medical supplies are running short, and research from Minnesota-based 3M Corporation found that KN95 masks are "reasonable to consider….as equivalent" to the N95 variety.
With the supply of N95 masks running low due to a global surge in demand as the COVID-19 outbreak worsens, the FDA issued an Emergency Use Authorization (EUA) on March 24 to allow American health care workers to use masks made to specifications for five other countries (Australia, Brazil, Japan, South Korea, and Mexico) and Europe. But the Chinese-approved KN95 masks were left off the list.
Despite that, importers were finding ad hoc methods of getting the KN95 masks into the United States. Even though hospitals and other health care providers were forbidden from buying them, the KN95 masks could be sold to the general public or donated to first responders."
The KN95 designation is a Chinese government standard that is widely considered to be equivalent to the N95 masks approved by American regulators. Guidance issued by the Centers for Disease Control (CDC) says the KN95 masks are "suitable alternatives" to the N95 mask when medical supplies are running short, and research from Minnesota-based 3M Corporation found that KN95 masks are "reasonable to consider….as equivalent" to the N95 variety.
With the supply of N95 masks running low due to a global surge in demand as the COVID-19 outbreak worsens, the FDA issued an Emergency Use Authorization (EUA) on March 24 to allow American health care workers to use masks made to specifications for five other countries (Australia, Brazil, Japan, South Korea, and Mexico) and Europe. But the Chinese-approved KN95 masks were left off the list.
Despite that, importers were finding ad hoc methods of getting the KN95 masks into the United States. Even though hospitals and other health care providers were forbidden from buying them, the KN95 masks could be sold to the general public or donated to first responders."