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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 K872996
Device Name NATURAL-TOUCH (TM) SURGEON'S GLOVE
Applicant
Hands-On Packaging , Ltd.
1515 Dotzert Ct.
Units 5 And 6
Waterloo, Ontario N2l 6a7,  CA
Applicant Contact ERIC PENROSE
Correspondent
Hands-On Packaging , Ltd.
1515 Dotzert Ct.
Units 5 And 6
Waterloo, Ontario N2l 6a7,  CA
Correspondent Contact ERIC PENROSE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received08/03/1987
Decision Date 03/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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