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 ID | K210496 |
510k Number | K210496 |
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 |
Contact | Mesh Gelman |
Correspondent | Mesh Gelman Nautilus Gloves LLC 767 5th Avenue 15th Floor Manhattan, NY 10153 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-22 |
Decision Date | 2021-05-26 |