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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K181106
Device Name Powder Free Nitrile Patient Examination Gloves, Blue Color
Applicant
Jiangsu Dongxin Medical Technology Co., Ltd.
Longjin Rd., The Economic Development Zone Of Sucheng
Suqian,  CN 223800
Applicant Contact Deng Yujie
Correspondent
Beijing Easylink Co., Ltd.
Rm. F302 Bldg., 41, Jing Cheng Ya Ju
Ct.yard 6 Of Southern Dou Ge Zhuang
Beijing,  CN 100021
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received04/26/2018
Decision Date 01/16/2019
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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