Disposable Nitrile Examination Glove

Polymer Patient Examination Glove

Inner Mongolia Boming Medical Supplies Co., Ltd.

The following data is part of a premarket notification filed by Inner Mongolia Boming Medical Supplies Co., Ltd. with the FDA for Disposable Nitrile Examination Glove.

Pre-market Notification Details

Device IDK212467
510k NumberK212467
Device Name:Disposable Nitrile Examination Glove
ClassificationPolymer Patient Examination Glove
Applicant Inner Mongolia Boming Medical Supplies Co., Ltd. Room 326, New Industrial Park Management Committee Office Tumet Right Banner Baotou,  CN 014017
ContactGuo Hua
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-06
Decision Date2021-11-04

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