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.
|Device Name:||Disposable Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) - Blue/Black/Purple|
|Classification||Polymer 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|
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, CN 200120
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|