K232820 is an FDA 510(k) clearance for the HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806). 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 4, 2024, 265 days after receiving the submission on September 13, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K232820 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2023 |
| Decision Date | June 04, 2024 |
| 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 |