K050786 is an FDA 510(k) clearance for the BARRIER SURGICAL GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Molnlycke Health Care (Newton, US). The FDA issued a Cleared decision on May 9, 2005, 42 days after receiving the submission on March 28, 2005.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K050786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2005 |
| Decision Date | May 09, 2005 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |