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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 K211864
Device Name Powder Free Nitrile Patient Examination Gloves, Blue Color
Applicant
Siyang Jaysun Medtech Co., Ltd.
#26 Changjiang Rd., Siyang Economic Development Zone
Suqian,  CN 223700
Applicant Contact Chen Fang
Correspondent
Beijing Easy-Link Company
Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Ct.yard 6 Of
Southern Dou Ge Zhuang,Chaoyang District
Beijing,  CN 100121
Correspondent Contact Chu Xiaoan
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/16/2021
Decision Date 01/21/2022
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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