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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.
#36 Leizhou Rd., 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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