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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 K151680
Device Name Powder Free Nitrile Patient Examination Gloves, Blue Color
Applicant
SUQIAN XINGYE GLOVE CO, LTD
DONGWU ROAD, THE ECONOMIC DEVELOPMENT ZONE
SUQIAN CITY,  CN 223800
Applicant Contact JIAN ZHONG-DENG
Correspondent
Beijing Easylink CO., LTD
Rm. F302 Bldg., 41, Jing Cheng Ya Ju,
Courtyard 6 of Southern Dou Ge Zhuang
Beijing,  CN 100121
Correspondent Contact CHU XIAOAN
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/22/2015
Decision Date 02/12/2016
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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