Spin Care Disposable Protective Mask Level 3

Spin Care Disposable Protective Mask Level 3 is an FDA 510(k)-cleared medical device (K212109) manufactured by Spintech, 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 13, 2021. Regulation: 8.