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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 K063582
Device Name ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
Applicant
Zimmer, Inc.
200 W. Ohio Ave.
P.O. Box 10
Dover,  OH  44622
Applicant Contact CINDY J DICKEY
Correspondent
Zimmer, Inc.
200 W. Ohio Ave.
P.O. Box 10
Dover,  OH  44622
Correspondent Contact CINDY J DICKEY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/01/2006
Decision Date 04/26/2007
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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