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Shen Wei (Usa), Inc.
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POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM is an FDA 510(k)-cleared medical device (K113233) manufactured by Shen Wei (Usa), Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 28, 2012. Regulation: 8.