The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Blockade Surgical Gown.
| Device ID | K150598 |
| 510k Number | K150598 |
| Device Name: | Blockade Surgical Gown |
| Classification | Gown, Surgical |
| Applicant | Medline Industries, Inc. One Medline Place Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen Medline Industries, Inc. One Medline Place Mundelein, IL 60060 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-09 |
| Decision Date | 2016-04-28 |