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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 K220237
Device Name Disposable Medical Nitrile Examination Gloves
Applicant
Fujian Jixiang Medical Technology Co.,Ltd
29 Tingzhou Ave., Cewu Town, Changting County
Longyan,  CN 366399
Applicant Contact Jiatian Yang
Correspondent
Cnmed Consultant
31 Archer St.
Upper Mount Gravatt,  AU 4122
Correspondent Contact Johnson Liu
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/27/2022
Decision Date 08/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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