Disposable Nitrile Powder-Free Examination Gloves (Tested For Use With Chemotherapy Drugs)

Polymer Patient Examination Glove

Shandong Maida Medical Technology Co.,Ltd.

The following data is part of a premarket notification filed by Shandong Maida Medical Technology Co.,ltd. with the FDA for Disposable Nitrile Powder-free Examination Gloves (tested For Use With Chemotherapy Drugs).

Pre-market Notification Details

Device IDK221271
510k NumberK221271
Device Name:Disposable Nitrile Powder-Free Examination Gloves (Tested For Use With Chemotherapy Drugs)
ClassificationPolymer Patient Examination Glove
Applicant Shandong Maida Medical Technology Co.,Ltd. Room 102, Eastern Building, No.166, South 1st Road Development Zone Dongying,  CN 257000
ContactKitty Xu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-07-27

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.