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Kimberly-Clark Corp.
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ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN is an FDA 510(k)-cleared medical device (K080795) manufactured by Kimberly-Clark Corp.. 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 September 2, 2008. Regulation: 8.