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Regent Medical Americas, LLC
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BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE is an FDA 510(k)-cleared medical device (K050184) manufactured by Regent Medical Americas, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 15, 2005. Regulation: 8.