Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy)

Polymer Patient Examination Glove

Jiangsu Cureguard Glove Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Disposable Nitrile Medical Examination Glove (tested For Use With Chemotherapy).

Pre-market Notification Details

Device IDK211608
510k NumberK211608
Device Name:Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy)
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu Cureguard Glove Co., Ltd. No. 65 Shenzhen Road, The Economic Development Zone Suqian,  CN 223800
ContactGuo Hua
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 Received2021-05-25
Decision Date2021-08-05

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