Medline Level 4 Surgical Gown with Breathable Sleeves

Medline Level 4 Surgical Gown with Breathable Sleeves is an FDA 510(k)-cleared medical device (K242844) 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 February 25, 2025. Regulation: 8.