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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 K212899
Device Name Disposable Vinyl/Nitrile Blend Medical Examination Gloves
Applicant
Bytech(Dongtai) Co., Ltd.
Xinyuan Industrial Park,Tangyang Town
Dongtai,  CN 224233
Applicant Contact Wang Cheng
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received09/13/2021
Decision Date 12/11/2021
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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