The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Medical Pvc Examination Gloves.
|Device Name:||Medical PVC Examination Gloves|
|Classification||Vinyl Patient Examination Glove|
|Applicant||Jiangxi Hongda Medical Equipment Group Ltd. 39 South Shengli Road, 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|