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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 K173228
Device Name U-MED Powder Free Polyethylene Examination Gloves,Blue Color
Applicant
Jiangsu U-Med Rubber & Plastic Products Co., Ltd.
Luzhuang Rd., Suyu High-Tech Zone,
Suqian,  CN 223804
Applicant Contact Chen Ye
Correspondent
Beijing Easylink Co., Ltd.
Rm. F302 Bldg., 41, Jing Cheng Ya Ju
Courtyard 6 Of Southern Dou Ge Zhuang
Beijing,  CN 100021
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received10/04/2017
Decision Date 02/20/2018
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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