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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 K182851
Device Name SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Applicant
O&M Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Applicant Contact Angela L. Bunn
Correspondent
O&M Halyard, Inc.
5405 Windward Pkwy.
Alpharetta,  GA  30004
Correspondent Contact Angela L. Bunn
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received10/10/2018
Decision Date 06/26/2019
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
Recalls CDRH Recalls
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