U-MED Powder Free Polyethylene Examination Gloves,Blue Color

Polymer Patient Examination Glove

Jiangsu U-MED Rubber & Plastic Products Co.,Ltd.

The following data is part of a premarket notification filed by Jiangsu U-med Rubber & Plastic Products Co.,ltd. with the FDA for U-med Powder Free Polyethylene Examination Gloves,blue Color.

Pre-market Notification Details

Device IDK173228
510k NumberK173228
Device Name:U-MED Powder Free Polyethylene Examination Gloves,Blue Color
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. Luzhuang Road, Suyu High-Tech Zone, Suqian,  CN 223804
ContactChen Ye
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 Received2017-10-04
Decision Date2018-02-20
Summary:summary

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