The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Prevention Coolzone Gown.
| Device ID | K172954 |
| 510k Number | K172954 |
| Device Name: | Medline Prevention CoolZone Gown |
| Classification | Gown, Surgical |
| Applicant | Medline Industries, Inc. 3 Lakes Drive Northfield, IL 60093 |
| Contact | Pauline Maralit |
| Correspondent | Pauline Maralit Medline Industries, Inc. 3 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 | 2017-09-26 |
| Decision Date | 2018-06-15 |
| Summary: | summary |