The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Medical Nitrile Examination Gloves (power Free, Blue).
|Device Name:||Medical Nitrile Examination Gloves (Power Free, Blue)|
|Classification||Polymer Patient Examination Glove|
|Applicant||Jiangxi Hongda Medical Equipment Group Ltd. 39 South Shengli RD. Jinxian County Nanchang, CN 331700|
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|