K232807 is an FDA 510(k) clearance for the Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869). This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Owens & Minor (O&M) Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on June 21, 2024, 283 days after receiving the submission on September 12, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K232807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2023 |
| Decision Date | June 21, 2024 |
| Days to Decision | 283 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |