Dukal Corporation AAMI Level 4 Open-Back Protective Gown

Dukal Corporation AAMI Level 4 Open-Back Protective Gown is an FDA 510(k)-cleared medical device (K212464) manufactured by Dukal Corporation. 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 March 29, 2022. Regulation: 8.