Disposable Surgical Face Mask (3P00B, C2900)

The Disposable Surgical Face Mask (models 3P00B and C2900) is a single-use, non-sterile mask intended to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material during surgical and infection control procedures. The 3P00B is a three-layer Level 2 mask, while the C2900 is a four-layer Level 3 mask, both with ear loops and aluminum nose pieces.

The subject device uses spun-bonded non-woven fabric for outer and inner layers with polyethylene melt-blown filtration layers, and polyester/spandex ear loops. It achieves particulate filtration efficiency of 98.85% (Level 2) and 98.84% (Level 3), and bacterial filtration efficiency of 99.9% for both levels. Key differences from the predicate include different materials (non-woven vs. polypropylene) and ear loop composition (polyester/spandex vs. nylon/spandex), though performance meets or exceeds requirements.

Testing complied with ASTM F2100-25, ASTM F2101, ASTM F1862, ASTM F3502, ISO 10993-5, ISO 10993-10, ISO 10993-23, EN 14683, and 16 CFR Part 1610 (flammability). All tests demonstrated non-cytotoxic, non-irritating, and non-sensitizing results.

The subject device is substantially equivalent to predicate K220597 because it has identical indications for use, same product code (FXX) and regulatory class (Class II), same design features with ear loops, and equivalent or superior performance across all critical parameters including bacterial filtration efficiency, fluid resistance, and flammability. Material differences and higher particulate filtration efficiency do not affect safety or effectiveness, supported by biocompatibility testing showing no adverse effects.