
Azac Group
Free shipping on orders over $99 · 30-day returns
Protect X Level 3 Isolation Gown is an FDA 510(k)-cleared medical device (K211538) manufactured by Azac Group. 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 16, 2021. Regulation: 8.