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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 K212735
Device Name Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
Applicant
Xingyu Medical Tech Co., Ltd.
No. 2189 Yaoqian Road, Gaomi Economic Development Zone
Weifang,  CN
Applicant Contact Cathrine Luan
Correspondent
Shanghai Sungo Management Consulting Company Limited
Room 1309, Dongfang Building, 1500#Century Ave
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Code
LZC  
Date Received08/30/2021
Decision Date 01/11/2022
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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