Sparta 3-Ply Surgical Disposable Face Mask

Sparta 3-Ply Surgical Disposable Face Mask is an FDA 510(k)-cleared medical device (K220378) manufactured by Sparta East, 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 June 29, 2022. Regulation: 8.