Pairon Solutions LLC Warning Letter Details

Summary

Pairon Solutions LLC was cited for selling face masks (KN95, surgical, and 3-ply models) as unapproved medical devices without proper FDA authorization. The company made disease prevention and mitigation claims on their website and product packaging—including statements about FDA EUA listings, bacterial filtration efficiency, and compliance with standards like GB2626-2006 and ASTM F2100—that established these products as medical devices requiring premarket approval or an Investigational Device Exemption. The FDA determined these masks were being marketed and distributed in the United States without the required regulatory clearance or authorization.