Medline Open-back Level 3 Protective Gown

Medline Open-back Level 3 Protective Gown is an FDA 510(k)-cleared medical device (K233526) manufactured by Medline Industries, LP. 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 4, 2024. Regulation: 8.