Powder Free Nitrile Patient Examination Gloves, Blue Color

Polymer Patient Examination Glove

JiangSu DongXin Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Dongxin Medical Technology Co., Ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue Color.

Pre-market Notification Details

Device IDK181106
510k NumberK181106
Device Name:Powder Free Nitrile Patient Examination Gloves, Blue Color
ClassificationPolymer Patient Examination Glove
Applicant JiangSu DongXin Medical Technology Co., Ltd LongJin Road, The Economic Development Zone Of SuCheng Suqian,  CN 223800
ContactDeng Yujie
CorrespondentChu Xiaoan
Beijing Easylink Co., Ltd Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 of Southern Dou Ge Zhuang Beijing,  CN 100021
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-26
Decision Date2019-01-16
Summary:summary

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