Makrite Industries, Inc. · Class II · Cleared Jan 5, 2026
| K-number | K252650 |
| Device name | Disposable Medical Face Mask |
| Applicant | Makrite Industries, Inc. |
| Product code | FXX |
| Device class | Class II |
| Decision date | Jan 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4040 |
The Disposable Medical Face Mask is a single-use, non-sterile device worn by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material during infection control procedures. It is available in three filtration levels (Level 1, 2, and 3) with options for three or four pleats, ear loops or ties, and optional visor attachment.
The device is a three-layer construction with spun-bond polypropylene outer and inner layers and melt-blown polypropylene middle filter layer, with material density varying by level. Key differences from predicate include nylon/spandex ear loops versus spandex-only, iron nose piece versus steel, and testing to more recent ASTM standards (F3502-2022a versus F2299-17 for particulate filtration). Color options are blue and black versus predicate's five colors.
ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ASTM F2100 (performance specification), ASTM F2101 (bacterial filtration efficiency), ASTM F1862/F1862M-24 (synthetic blood resistance), EN 14683:2019 (differential pressure), ASTM F3502-2022a (sub-micron particulate filtration), and 16 CFR 1610 (flammability).
View the full FDA submission: accessdata.fda.gov