The following data is part of a premarket notification filed by Siyang Threeguard Medical Supplies Co.,ltd. with the FDA for Disposable Nitrile Medical Examination Glove (tested For Use With Chemotherapy Drugs).
|Device Name:||Disposable Nitrile Medical Examination Glove (Tested For Use With Chemotherapy Drugs)|
|Classification||Polymer Patient Examination Glove|
|Applicant||Siyang Threeguard Medical Supplies Co.,Ltd. East Of Nanhai Road And South Of Guilin Road, Economic Development Zone, Siyang County Suqian, CN 223799|
Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, CN 200120
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|