Savvy Mask - Level 3 Surgical Face Mask

Savvy Mask - Level 3 Surgical Face Mask is an FDA 510(k)-cleared medical device (K213406) manufactured by Texas Medplast, LLC. 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 November 17, 2021. Regulation: 8.