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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K142992
Device Name TULIP Natural Rubber Latex Surgeon's Glove (Powdered)
Applicant
SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD
No.36 Leizhou Road, Xinghuo Development Area
Fengxian District
Shanghai,  CN 201419
Applicant Contact Xiaoyan Wang
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 Number878.4460
Classification Product Code
KGO  
Date Received10/16/2014
Decision Date 03/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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