Medline Orbis LVL 3 Surgical Gown

Medline Orbis LVL 3 Surgical Gown is an FDA 510(k)-cleared medical device (K220333) 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 May 17, 2022. Regulation: 8.