Cardinal HealthTM Poly-Coated Open-Back Protective Gown

K182830 is the FDA 510(k) clearance record for Cardinal HealthTM Poly-Coated Open-Back Protective Gown, a class II device, cleared for Cardinal Health200, LLC on 2019-04-26 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 26 510(k) clearances for Cardinal Health200, LLC, from 2011-10-20 to 2024-08-23. As of 2026-09-10, FDA records show no recalls naming K182830.