K023167 is an FDA 510(k) clearance for the BREATHABLE SURGICAL GOWN. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on October 2, 2002, 9 days after receiving the submission on September 23, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K023167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2002 |
| Decision Date | October 02, 2002 |
| Days to Decision | 9 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 |