The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Disposable Surgical Gowns/drapes.
| Device ID | K032666 |
| 510k Number | K032666 |
| Device Name: | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES |
| Classification | Drape, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. 1170 S. NORTHPOINT BLVD. Waukegan, IL 60085 |
| Contact | Lara Simmons |
| Correspondent | Lara Simmons MEDLINE INDUSTRIES, INC. 1170 S. NORTHPOINT BLVD. Waukegan, IL 60085 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2005-03-16 |