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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K243604
Device Name 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
Applicant
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Applicant Contact Caitlin Senter
Correspondent
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Correspondent Contact Caitlin Senter
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received11/21/2024
Decision Date 08/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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