K211399 is an FDA 510(k) clearance for the Sterile Level 3 Surgical Gown. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Barco Tekstil Sanayi VE Ticaret A.S. (Istanbul, TR). The FDA issued a Cleared decision on July 22, 2022, 443 days after receiving the submission on May 5, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K211399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2021 |
| Decision Date | July 22, 2022 |
| Days to Decision | 443 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 |