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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 K210276
Device Name Disposable Nitrile Gloves
Applicant
Fujian Ercon Medical Management Co., Ltd.
Unit 701, Xinyi International Center,
#3911 Huandao E. Rd., Siming District
Xiamen,  CN 361000
Applicant Contact Lin Ruijin
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 Received02/01/2021
Decision Date 04/16/2021
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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