K251860 is an FDA 510(k) clearance for the Copioumed AAMI 3 Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Copioumed International, Inc. (Taipei City, TW). The FDA issued a Cleared decision on February 26, 2026, 254 days after receiving the submission on June 17, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K251860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2025 |
| Decision Date | February 26, 2026 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| 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 |