K251967 is an FDA 510(k) clearance for the HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by O&M Halyard, Inc. (Alpharetta, US). The FDA issued a Cleared decision on March 18, 2026, 265 days after receiving the submission on June 26, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K251967 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2025 |
| Decision Date | March 18, 2026 |
| Days to Decision | 265 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 |