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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 K002922
Device Name OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
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 Received09/19/2000
Decision Date 10/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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