The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Gore-tex Non-sterile Surgical Gowns.
| Device ID | K052833 |
| 510k Number | K052833 |
| Device Name: | GORE-TEX NON-STERILE SURGICAL GOWNS |
| Classification | Drape, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Jennifer Mason |
| Correspondent | Jennifer Mason MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-06 |
| Decision Date | 2006-02-15 |