The following data is part of a premarket notification filed by Hebei Astro Medical Supply Co., Ltd with the FDA for Vinyl Exam Gloves.
|Device Name:||Vinyl Exam Gloves|
|Classification||Vinyl Patient Examination Glove|
|Applicant||Hebei Astro Medical Supply Co., Ltd East Of Xiaoxixian, West Of Jingsan Street, South Of Weiwu Road, North Of Weiqi Road, Jinxhou Eco Jinzhou, CN 052260|
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|