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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medical Glove, Specialty
510(k) Number K212639
Device Name Disposable Medical Nitrile Examination Gloves (Non sterile)
Applicant
Jiangsu Nanfang Medical Co., Ltd.
# 1 Guoxiang Rd., Wujin Economic Development Zone, Wujin
Changzhou,  CN 213149
Applicant Contact Xia Li
Correspondent
Cnmed Consultant
31 Archer St.
Upper Mount Gravatt,  AU 4122
Correspondent Contact Johnson Liu
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received08/20/2021
Decision Date 12/08/2021
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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