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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 K171616
Device Name Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
Applicant
Shandong Xingyu Gloves Co., Ltd
No.2158,Yaoqian Road,Economic Development Zone
Gaomi,  CN 261502
Applicant Contact Xu Qiang
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 Received06/01/2017
Decision Date 07/20/2017
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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