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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 K013603
Device Name MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65
Applicant
Ansell Healthcare Products, Inc.
1875 Harsh Ave. SE
Massillon,  OH  44646
Applicant Contact JAMES R CHATTERTON
Correspondent
Ansell Healthcare Products, Inc.
1875 Harsh Ave. SE
Massillon,  OH  44646
Correspondent Contact JAMES R CHATTERTON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/31/2001
Decision Date 11/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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