Cardinal HealthTM Poly-Coated Open-Back Protective Gown

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is an FDA 510(k)-cleared medical device (K182830) manufactured by Cardinal Health200, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 25, 2019. Regulation: 8.