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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 K211063
Device Name HALYARD Flexaprene Green Powder-Free Exam Glove
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  
Date Received04/09/2021
Decision Date 11/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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