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 |