K230380 is an FDA 510(k) clearance for the Surgical Face Masks, Model: EFMDS-L50Pn BLU. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Iris USA (Pleasant Prairie, US). The FDA issued a Cleared decision on August 3, 2023, 171 days after receiving the submission on February 13, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K230380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2023 |
| Decision Date | August 03, 2023 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |