Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)

Polymer Patient Examination Glove

Jiujiang Taixin Technology Co., Ltd.

The following data is part of a premarket notification filed by Jiujiang Taixin Technology Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK212919
510k NumberK212919
Device Name:Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Jiujiang Taixin Technology Co., Ltd. Zone A, Ruichang Science And Technology Park Ruichang City,  CN 332200
ContactLi Xiaojie
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-14
Decision Date2021-12-15

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