Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) - Blue/Black/Purple

Polymer Patient Examination Glove

Jiangsu Bytech Medical Supplies Co.,Ltd.

The following data is part of a premarket notification filed by Jiangsu Bytech Medical Supplies Co.,ltd. with the FDA for Disposable Nitrile Examination Gloves (tested For Use With Chemotherapy Drugs) - Blue/black/purple.

Pre-market Notification Details

Device IDK220382
510k NumberK220382
Device Name:Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) - Blue/Black/Purple
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu Bytech Medical Supplies Co.,Ltd. NO.88 Junshi Road, Petroleum Equipment Industrial Park Jianyang Town, Jianhu County Yancheng City,  CN 224700
ContactShen Hongxing
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-10
Decision Date2022-04-21

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