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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K093516
Device Name NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES
Applicant
Summit Glove, Inc.
310 S. Grant St.
Minerva,  OH  44657
Applicant Contact JAMES MOORE
Correspondent
Summit Glove, Inc.
310 S. Grant St.
Minerva,  OH  44657
Correspondent Contact JAMES MOORE
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/13/2009
Decision Date 06/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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