The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Level 2 Surgical Gown (eclipse Non-reinforced), Medline Level 3 Surgical Gown (eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (sirus Non-reinforced), Medline Level 3 Surgical Gown (sirus Fabric Reinforced), Medline Level 3 Surgical.
| Device ID | K190950 |
| 510k Number | K190950 |
| Device Name: | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical |
| Classification | Gown, Surgical |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Pauline Maralit |
| Correspondent | Pauline Maralit Medline Industries, Inc. 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 | 2019-04-11 |
| Decision Date | 2019-07-04 |