Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

This is a disposable, non-sterile surgical mask (model EFX3PLBLKMSK300) designed to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate matter during medical procedures. It is a single-use, over-the-counter device intended for infection control practices to reduce exposure to blood and body fluids.

The device is a flat-pleated three-layer mask with black outer and inner layers of spun-bond polypropylene and a melt-blown polypropylene filter middle layer. It features elastic ear loops made of polypropylene and spandex, a galvanized wire nose bridge coated with polyethylene, and measures 175 mm in length and 95 mm in width. The only difference from the predicate device is color: the subject device is black while the predicate is blue.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and sensitization), ASTM F2100-23 (face mask performance), ASTM F1862 (fluid resistance), ASTM F2101 (bacterial filtration efficiency), ASTM F3502 (sub-micron particulate filtration), EN 14683 (medical face mask requirements), and 16 CFR 1610 (flammability).

The subject device is substantially equivalent to predicate K223823 because it is identical in design, materials, manufacturing process, intended use, and performance characteristics, differing only in color (black versus blue). All biocompatibility and performance tests demonstrated equivalent or superior results, meeting Level 2 and Level 3 ASTM performance requirements just as the predicate device does.