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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name medical glove, specialty
510(k) Number K191230
Device Name Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
Applicant
O & M Halyard, Inc.
9120 Lockwood Blvd
Mechanicsville,  VA  23116
Applicant Contact Steve Dowdlley
Correspondent
O & M Halyard, Inc.
9120 Lockwood Blvd
Mechanicsville,  VA  23116
Correspondent Contact Steve Dowdlley
Regulation Number880.6250
Classification Product Code
LZC  
Date Received05/08/2019
Decision Date 11/08/2019
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
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