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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K032190
Device Name DISPOSABLE POWDERED VINYL EXAM GLOVES
Applicant
Synmertex Co, Ltd.
1404 Greenport Ave.
Rowland Heights,  CA  91748
Applicant Contact ALBERT LING
Correspondent
Synmertex Co, Ltd.
1404 Greenport Ave.
Rowland Heights,  CA  91748
Correspondent Contact ALBERT LING
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/17/2003
Decision Date 08/14/2003
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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