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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 K213325
Device Name Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
Applicant
Anhui Xinyisheng Medical Technology Co.,Ltd
#999 N. Of The Intersection Of Tonghe Rd. And G343
Rd.
Suzhou,  CN 234300
Applicant Contact Wei Wei Tang
Correspondent
Cnmed Consulting
31 Archer St.
Upper Mount Gravatt,  AU 4122
Correspondent Contact Johnson Liu
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received10/05/2021
Decision Date 01/28/2022
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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