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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 K142911
Device Name ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant
Huailai ZM Plastic Products Co., Ltd.
Sancheng Economic Development Zone, Huailai County
Zhangjiakou,  CN 075400
Applicant Contact ZHUAHAO ZHANG
Correspondent
Beijing Easylink Co., Ltd.
Rm. F302 Bldg., 41, Jing Cheng Ya Ju
Ct.yard 6 Of Southern Dou Ge Zhuang
Beijing,  CN 100121
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/06/2014
Decision Date 04/10/2015
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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