Donagamex Blue Performance Protective Gown

K203821 is the FDA 510(k) clearance record for Donagamex Blue Performance Protective Gown, a class II device, cleared for Dong Nai Garment Corporation (Donagamex) on 2021-12-17 under FDA product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection). FDA's definition for product code QPC reads: "A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are...". FDA records list one 510(k) clearance for Dong Nai Garment Corporation (Donagamex). As of 2026-09-10, FDA records show no recalls naming K203821.