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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 K142703
Device Name Powder-free PVC Vinyl Exam Gloves
Applicant
Hebei Grandeast Plastic Products Co., Ltd.
Industrial Park, Julu County
Xingtai,  CN 055250
Applicant Contact Wei Liu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/22/2014
Decision Date 01/15/2015
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
Predetermined Change
Control Plan Authorized		 No
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