The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Non-surgical Isolation Gown-.
| Device ID | K160471 |
| 510k Number | K160471 |
| Device Name: | Medline Non-Surgical Isolation Gown- |
| Classification | Gown, Isolation, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Pauline Maralit |
| Correspondent | Pauline Maralit MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2017-01-31 |