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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 K163146
Device Name POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
Applicant
Hebei Hongsen Plastics Technology Co, Ltd.
Estern Industrial Zone
Nangong,  CN 051800
Applicant Contact Shaozhang Nan
Correspondent
Beijing Believe Tech.Service Co., Ltd.
5-1206, Build 332, Dafangju, #25 Banbidian Rd., Liyuan
Tongzhou District
Beijing,  CN 101121
Correspondent Contact Ray Wang
Regulation Number880.6250
Classification Product Code
LZC  
Subsequent Product Code
LZA  
Date Received11/09/2016
Decision Date 02/13/2017
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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