
PolyConversions, Inc.
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PolyWear® Personal Protective Level 3 Gown is an FDA 510(k)-cleared medical device (K230384) manufactured by PolyConversions, Inc.. 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 August 10, 2023. Regulation: 8.