There are many complexities surrounding N95 masks and federally authorized KN95 masks, and the AAO is researching these on an ongoing basis. When preparing to purchase these masks, it may be helpful to first review OSHA’s guidance on occupational exposures. Additionally, the AAO COVID-19 Task Force has prepared a guide, “Interim Orthodontic PPE Summary Based on Current CDC and OSHA Guidelines.”
N95 face masks are regulated by the National Institute for Occupational Safety and Health (NIOSH) and the Centers for Disease Control and Prevention (CDC). Concerns have been raised about counterfeit versions of N95 masks entering the market. The CDC has outlined signs that a product may be counterfeit in its guide, “Counterfeit Respirators / Misrepresentation of NIOSH-Approval.”
On May 7th, the U.S. Food and Drug Administration (FDA) announced it was withdrawing its earlier emergency authorization of KN95 masks from all but 14 manufacturing facilities in China that it had approved. To view the list of the 14 remaining approved mask types/facilities, please click here.
The AAO has designated below suppliers offering N95 or KN95 masks, that responded to our query on this topic, indicating:
- That they purchase N95 masks from U.S.-based company on the CDC’s list of NIOSH-approved producers of N95 masks
- That they purchase KN95 masks from a company on the list of 14 approved facilities in China (link above).