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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 K211708
Device Name Disposable Medical Nitrile Gloves
Applicant
Jiangsu Health-Peace Medical Technology Co., Ltd.
Dongan Youdian St., Huangli Town, Wujin
Changzhou,  CN 213000
Applicant Contact Min Liu
Correspondent
Cnmed Consultant
31 Archer St.
Upper Mount Gravatt,  AU 4122
Correspondent Contact Johnson Liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received06/03/2021
Decision Date 08/17/2021
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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