The following data is part of a premarket notification filed by Shanghai Shengda Medical Applications Co., Ltd with the FDA for Powder Free Vinyl Examination Gloves.
|Device Name:||Powder Free Vinyl Examination Gloves|
|Classification||Vinyl Patient Examination Glove|
|Applicant||Shanghai Shengda Medical Applications Co., Ltd No. 608 Xingwen Road, North Development Zone, Jiading District Shanghai, CN 201815|
Manton Business And Technology Services 37 Winding Ridge Oakland, NJ 07436
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|