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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 K210777
Device Name Powder Free Nitrile Patient Examination Gloves, Blue Color
Applicant
Shandong Jieshi Medical Products Co., Ltd.
North Rd., Fumin Ave., Qinghe St., Caoxian County
Heze,  CN 274400
Applicant Contact Li Biao
Correspondent
Beijing Easy-Link Company
Rm. F302 Bldg., 41, Jing Cheng Ya Ju,
Courtyard 6 Of Southern Dou Ge Zhuang, Chaoyung District
Beijing,  CN 100121
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received03/15/2021
Decision Date 11/02/2021
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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