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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 Parkway
Alpharetta,  GA  30004
Applicant Contact Angela L. Bunn
Correspondent
O & M Halyard, Inc.
5405 Windward Parkway
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
Recalls CDRH Recalls
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