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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 K212497
Device Name Nitrile Examination Glove (Powder free, Blue)
Applicant
Jiangsu Jinlian Medical Technology Co., Ltd
No. 14 Factory Building, 1st Floor
West of Century Aveneul, Suqian Econo-Tech-Deve-Zone
Suqian,  CN 223800
Applicant Contact Wu Min
Correspondent
Beijin Believe-Med Technology Service Co., Ltd
Rm.912, Building#15, XiYueHui, No.5, YiHe North Rd.
FangShan District
Beigin,  CN 102401
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LZA  
Date Received08/09/2021
Decision Date 11/11/2021
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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