
PolyConversions, Inc.
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VR® Personal Protective Level 3 Gown (VR Gowns) is an FDA 510(k)-cleared medical device (K252940) 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 December 15, 2025. Regulation: 8.