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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 K132201
Device Name SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR
Applicant
ZIBO INTCO MEDICAL PRODUCTS CO., LTD.
12390 EAST END AVE.
CHINO,  CA  91710
Applicant Contact JOHN ZHAO
Correspondent
ZIBO INTCO MEDICAL PRODUCTS CO., LTD.
12390 EAST END AVE.
CHINO,  CA  91710
Correspondent Contact JOHN ZHAO
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/16/2013
Decision Date 11/27/2013
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
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