K230577 is an FDA 510(k) clearance for the Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL). This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi (Izmir, TR). The FDA issued a Cleared decision on August 16, 2023, 168 days after receiving the submission on March 1, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K230577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2023 |
| Decision Date | August 16, 2023 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA - Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |