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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 K211236
Device Name Disposable Vinyl Examination Gloves
Applicant
Tangshan Hongyun Healthcare Products Co., Ltd.
South Shenggezhuang Village,Pachigang Town, Luannan
Tangshan,  CN 063500
Applicant Contact Suying Le
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 Received04/26/2021
Decision Date 09/27/2021
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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