
Gmax Industries, Inc.
Free shipping on orders over $99 · 30-day returns
Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) is an FDA 510(k)-cleared medical device (K172987) manufactured by Gmax Industries, Inc.. 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 July 12, 2018. Regulation: 8.