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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K190018
Device Name Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Applicant
Ansell Healthcare Products, LLC
2301 Robb Dr.
Reno,  NV  89523
Applicant Contact Don Cronk
Correspondent
Ansell Healthcare Products, LLC
2301 Robb Dr.
Reno,  NV  89523
Correspondent Contact Don Cronk
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/04/2019
Decision Date 05/23/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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