O&M Halyard, Inc. · Class II · Cleared Dec 11, 2025
| K-number | K252941 |
| Device name | HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops |
| Applicant | O&M Halyard, Inc. |
| Product code | FXX |
| Device class | Class II |
| Decision date | Dec 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
The HALYARD Adult Face Mask with SO SOFT Lining and SO SOFT Earloops is a three-layer surgical mask intended to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material during medical procedures. It is a single-use, disposable, non-sterile device with earloops and a malleable nosepiece.
The subject device differs from the predicate in its outer layer material: Disney Printed Polyester/Cellulose instead of Lavender Polypropylene Spunbond. All other components—second layer (white polypropylene meltblown), inner layer (polyethylene terephthalate/polyethylene bicomponent), bindings, wire, earloops, and overall design—remain identical, including flat-pleated style, dimensions, and ultrasonic bonding method.
ASTM F2100 (surgical mask performance level 1), ASTM F2101 (bacterial filtration efficiency ≥95%), ASTM F3502 (particulate filtration efficiency ≥80%), EN 14683 (differential pressure <5.0 mm H₂O/cm²), ASTM F1862 (fluid resistance 80 mmHg), 16 CFR Part 1610 (flammability class 1), and ISO 10993 series (biocompatibility: acute systemic toxicity, sensitization, and irritation).
View the full FDA submission: accessdata.fda.gov