The following data is part of a premarket notification filed by Medline Industries, Lp. with the FDA for Medline Orbis Lvl 3 Surgical Gown.
| Device ID | K220333 |
| 510k Number | K220333 |
| Device Name: | Medline Orbis LVL 3 Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Medline Industries, LP. Three Lakes Drive Northfield, IL 60093 |
| Contact | Adam Ostrower |
| Correspondent | Adam Ostrower Medline Industries, LP. Three Lakes Drive Northfield, IL 60093 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-05-18 |