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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K012402
Device Name OMNI GRACE LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
Applicant
Omnigrace (Thailand) , Ltd.
7815 Vanderbilt Dr. NW
North Canton,  OH  44720
Applicant Contact WILLIAM E PATTON
Correspondent
Omnigrace (Thailand) , Ltd.
7815 Vanderbilt Dr. NW
North Canton,  OH  44720
Correspondent Contact WILLIAM E PATTON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received07/27/2001
Decision Date 10/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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