Procedure mask/Surgical mask/Face mask

The device is a three-layer, single-use, flat-pleated surgical mask designed to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. It is non-sterile and available in three ASTM F2100-23 levels (Level 1, 2, and 3) with multiple color and size options, featuring adjustable nose clips and elastic ear loops.

The subject device is a three-layer mask with polypropylene nonwoven inner and outer layers and polypropylene melt-blown middle layer. Key differences from predicates include minor dimension adjustments, varied grammage weights in the middle and outer layers across levels, yellow and white color options (versus predicate blue/black only), and updated test methods per ASTM F2100-23 standard rather than F2100-19.

ASTM F1862/F1862M-24 (synthetic blood penetration), ASTM F2101-23 (bacterial filtration efficiency), ASTM F2100-23 (performance specification), ASTM F3502-24 (particulate filtration efficiency), EN 14683:2019+AC:2019 (differential pressure), 16 CFR Part 1610 (flammability), ISO 10993-5/10/23 (biocompatibility: cytotoxicity, sensitization, irritation).

The subject device is substantially equivalent because it maintains identical indications for use, regulatory classification (Class II, 21 CFR 878.4040), product code, and predicate design (flat-pleated, three-layer, ear-loop attachment). All dimensional, material, and performance differences are minor or attributable to standard updates; the device meets or exceeds all applicable acceptance criteria for each ASTM F2100-23 level. Biocompatibility testing confirms no adverse effects despite color and grammage variations. Performance across fluid resistance, filtration efficiency, differential pressure, and flammability are equivalent or superior to predicates K220194 and K223232.