ProGear® Surgical Mask with Oxafence®, Model AV82030

ProGear® Surgical Mask with Oxafence®, Model AV82030 is an FDA 510(k)-cleared medical device (K231741) manufactured by Prestige Ameritech. 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 September 4, 2024. Regulation: 8.