The following data is part of a premarket notification filed by Tangshan Lanhai Medical Supplies Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves (powder Free, Purple-blue, Blue).
|Device Name:||Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)|
|Classification||Polymer Patient Examination Glove|
|Applicant||Tangshan Lanhai Medical Supplies Co., Ltd. South Side Of Zhongda Street, East Side Of Jinxiu Road, Chengxi Industrial Zone, Luannan County Tangshan, CN 063500|
Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No. 5, YiHe North Rd., FangShan District Beijing, CN 102401
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|