
Shen Wei USA, Inc.
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Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution is an FDA 510(k)-cleared medical device (K213142) manufactured by Shen Wei USA, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 27, 2022. Regulation: 8.

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