The following data is part of a premarket notification filed by Suqian Linglian Medical Technology Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves (non-sterile).
|Device Name:||Disposable Medical Nitrile Examination Gloves (Non-sterile)|
|Classification||Polymer Patient Examination Glove|
|Applicant||Suqian Linglian Medical Technology Co., Ltd No 1 Rd Wanpi Industrial Park, Xinshuguan Road, Shuyang County Suqian, CN 223699|
CNMED Consultant 31 Archer St Upper Mt Gravatt, AU 4122
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|