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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name vinyl patient examination glove
510(k) Number K202010
Device Name Disposable Vinyl Glove
Applicant
Better Health Medical Products Co., Ltd.
Zhangliu Road, Zhangdian District
Zibo,  CN 255087
Applicant Contact Xiaomeng Li
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Room608,No.738,Shangcheng Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received07/21/2020
Decision Date 10/16/2020
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
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