Dukal Corporation AAMI Level 4 Open-Back Protective Gown

K212464 is the FDA 510(k) clearance record for Dukal Corporation AAMI Level 4 Open-Back Protective Gown, a class II device, cleared for Dukal Corporation on 2022-03-30 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 8 510(k) clearances for Dukal Corporation, from 2012-05-04 to 2026-05-28. As of 2026-09-10, FDA records show no recalls naming K212464.