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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs
510(k) Number K260310
Device Name HALYARD* CHEMO360 Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL); HALYARD* Procedure Gown Tested for use with Chemotherapy Drugs (L, XXL)
Applicant
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Applicant Contact Natrisya Nur Abdul Rahman
Correspondent
O&M Halyard, Inc.
1220 Old Alpharetta Rd.
Suite 320
Alpharetta,  GA  30005
Correspondent Contact Natrisya Nur Abdul Rahman
Regulation Number878.4040
Classification Product Code
QSO  
Date Received01/30/2026
Decision Date 10/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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