Paneffort AAMI Level 3 Isolation Gown

Paneffort AAMI Level 3 Isolation Gown is an FDA 510(k)-cleared medical device (K212717) manufactured by Paneffort, 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 29, 2022. Regulation: 8.