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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 K211904
Device Name Vinyl Glove
Applicant
Jiangsu Dihong Industry and Trade Co., Ltd.
Dongxiaodian Industrial Park
Shuyang,  CN 223616
Applicant Contact Sue Chen
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.608, No.738,Shangcheng Rd.,Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received06/21/2021
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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