Powder Free Nitrile Patient Examination Gloves, Blue Color

Polymer Patient Examination Glove

Shandong Shangwei Medical Products Co.,Ltd

The following data is part of a premarket notification filed by Shandong Shangwei Medical Products Co.,ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue Color.

Pre-market Notification Details

Device IDK210779
510k NumberK210779
Device Name:Powder Free Nitrile Patient Examination Gloves, Blue Color
ClassificationPolymer Patient Examination Glove
Applicant Shandong Shangwei Medical Products Co.,Ltd North Road, Fumin Avenue, Qinghe Street, Caoxian County Heze,  CN 274400
ContactLi Hua
CorrespondentChu Xiaoan
Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang, Chaoyung District Beijing,  CN 100121
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-11-10

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.