Yes, respirators approved under standards used in other countries, such as KN95, are allowed to be used in the US during the COVID-19 pandemic.
According to the FDA’s website:
“The U.S. Food and Drug Administration (FDA) is working diligently to mitigate any potential shortages in the supply chain and taking action to assure health care personnel on the front lines have sufficient supplies of respiratory protective devices. The FDA concluded, based on the totality of scientific evidence available, that certain imported respirators that are not National Institute for Occupational Safety and Health (NIOSH)-approved are appropriate to protect the public health or safety.”
Link to original article:
https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns-during-covid-19-pandemic
During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.
Link to original article:
We have been supplying local PPE suppliers, pharmaceutical laboratories, and the Brazilian Federal government with our masks. We entrusted SGS, a third-party, probably the most internationally renowned certifying body, to testify the legality and conformity of our products.
To further protect the consumers, the CDC offers the International Respirator Assessment that takes requests from federal and state agencies, employers, and healthcare systems to evaluate the quality of the masks. The evaluation conclusions following the assessment processes are legal binding and have on which been a basis to kick out any careless suppliers that fail to keep their quality commitment.
