The following data is part of a premarket notification filed by Humanwell Healthcare Group Medical Supplies Co., Ltd. with the FDA for Medical Examination Gloves (nitrile) (xs, S, M, L, Xl).
|Device Name:||Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)|
|Classification||Polymer Patient Examination Glove|
|Applicant||Humanwell Healthcare Group Medical Supplies Co., Ltd. 14th F, 1500# Century Avenue Wuhan, CN|
Shanghai Sungo Management Consulting Company Limited 14th F, 1500# Century Avenue Shanghai, CN 200122
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|