Disposable Nitrile Gloves

Polymer Patient Examination Glove

Jiangsu Shenglijie Safety Products Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Shenglijie Safety Products Co., Ltd with the FDA for Disposable Nitrile Gloves.

Pre-market Notification Details

Device IDK212009
510k NumberK212009
Device Name:Disposable Nitrile Gloves
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu Shenglijie Safety Products Co., Ltd No.88 SI Road Nantong,  CN 226401
ContactAndy Jiang
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room 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 Received2021-06-28
Decision Date2021-09-15

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