
Cardinal Health 200, LLC
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Cardinal Health Poly Reinforced Surgical Gown is an FDA 510(k)-cleared medical device (K253243) manufactured by Cardinal Health 200, 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 April 27, 2026. Regulation: 8.