Oregon Firm Gets Warning Letter for Unapproved Face Masks

The FDA has sent a warning letter to Pairon Solutions of Portland, Ore., for marketing several face masks as medical devices without the agency’s approval.

The masks in question are branded as Arun KN95 folding face mask, Deming surgical mask and Pairon 3Ply face mask.

The agency objected to various claims on the company’s website, paironsolutionsppe.com, including that the Arun KN95 folding face mask is “listed on FDA [Emergency Use Authorization] for Non-[National Institute for Occupational Safety and Health] Devices” and that the Deming surgical mask provides 99 percent bacterial efficiency and complies with the ASTM F2100 standard. The statements no longer appear on the website.