Vinyl Glove

Vinyl Patient Examination Glove

Jiangsu Dihong Industry And Trade Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Dihong Industry And Trade Co., Ltd. with the FDA for Vinyl Glove.

Pre-market Notification Details

Device IDK211904
510k NumberK211904
Device Name:Vinyl Glove
ClassificationVinyl Patient Examination Glove
Applicant Jiangsu Dihong Industry And Trade Co., Ltd. Dongxiaodian Industrial Park Shuyang,  CN 223616
ContactSue Chen
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738,Shangcheng Rd.,Pudong Shanghai,  CN 200120
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-21
Decision Date2021-09-17

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