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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 K213600
Device Name Medical nitrile examination gloves (Model: SH001)
Applicant
Jiangxi Sanhao Medical Instruments Co.,Ltd
Chengxi Industrial Park, Jishui County,
Ji'An,  CN 331699
Applicant Contact Wangfenfang No Last Name provided
Correspondent
Share Info (Guangzhou) Medical Consultant , Ltd.
# 1919-1920, Bldg. D3, Minjie Plz., Shuixi Rd.,
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number880.6250
Classification Product Code
LZA  
Date Received11/15/2021
Decision Date 02/19/2022
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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