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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 K211781
Device Name Disposable Nitrile Gloves
Applicant
Jiangsu Jinke Protective Equipment Co., Ltd.
West Shuangyang Rd.(South Side), Sihong Economic
Development Zone
Suqian,  CN 223900
Applicant Contact Mia Lai
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/09/2021
Decision Date 09/29/2021
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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