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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 K171615
Device Name Xingyu Nitrile Powder Free Patient Examination Gloves, White color
Applicant
Shandong Xingyu Gloves Co., Ltd.
#2158,Yaoqian Rd.,Economic Development Zone
Gaomi,  CN 261502
Applicant Contact Xu Qiang
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
LZA  
Date Received06/01/2017
Decision Date 07/31/2017
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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