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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 K192241
Device Name Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Applicant
O&M Haylard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Steven Dowdley
Correspondent
O&M Haylard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Steven Dowdley
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received08/19/2019
Decision Date 03/13/2020
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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