K243010 is an FDA 510(k) clearance for the Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804). 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 May 30, 2025, 246 days after receiving the submission on September 26, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K243010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2024 |
| Decision Date | May 30, 2025 |
| Days to Decision | 246 days |
| Submission Type | Abbreviated |
| 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 |