Nitrile Glove

Polymer 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 Nitrile Glove.

Pre-market Notification Details

Device IDK211252
510k NumberK211252
Device Name:Nitrile Glove
ClassificationPolymer 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 CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-06-25

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