The following data is part of a premarket notification filed by Shandong Shangwei Medical Products Co.,ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
|Device Name:||Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)|
|Classification||Vinyl Patient Examination Glove|
|Applicant||Shandong Shangwei Medical Products Co.,Ltd North Road, Fumin Avenue, Qinghe Street, Caoxian County Heze, CN 274400|
Beijing Easy-Link Company Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang, Chaoyung District Beijing, CN 100121
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|