
O&M Halyard, Inc.
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Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid is an FDA 510(k)-cleared medical device (K243604) manufactured by O&M Halyard, Inc.. This device is classified under the General Hospital specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 17, 2025. Regulation: 8.

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