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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 K202622
Device Name Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
Applicant
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Applicant Contact Steven Dowdley
Correspondent
O&M Halyard, Inc.
1 Edison Dr.
Alpharetta,  GA  30005
Correspondent Contact Steven Dowdley
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received09/10/2020
Decision Date 01/07/2021
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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