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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 K110857
Device Name POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
Applicant
SHANDONG ZHANPENG MEDICAL PRODUCTS CO., LTD
12390 EAST END AVE.
CHINO,  CA  91710
Applicant Contact FRANK LIU
Correspondent
SHANDONG ZHANPENG MEDICAL PRODUCTS CO., LTD
12390 EAST END AVE.
CHINO,  CA  91710
Correspondent Contact FRANK LIU
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/28/2011
Decision Date 07/15/2011
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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