Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3

Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 is an FDA 510(k)-cleared medical device (K221559) manufactured by Stringking. 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 22, 2023. Regulation: 8.