The following data is part of a premarket notification filed by Nautilus Gloves Llc with the FDA for Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-rated Exam Gloves.
|Device Name:||Nautilus Nitrile Exam Gloves, Nautilus Nitrile Chemo-Rated Exam Gloves|
|Classification||Polymer Patient Examination Glove|
|Applicant||Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan, NY 10153|
Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan, NY 10153
|CFR Regulation Number||880.6250 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|