KP Protective Face Mask

The KP Protective Face Mask is a non-sterile, single-use surgical mask consisting of three nonwoven polypropylene layers designed to cover the user's nose and mouth. It is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material.

The device features a three-layer construction (spunbond outer layer, melt-blown filter layer, and spunbond inner layer) with a polypropylene-clad adjustable nose wire and elastic ear loops made of nylon and polyurethane. Dimensions are approximately 205±10mm length and 85.1±6.4mm width. Key differences from the predicate include the use of melt-blown polypropylene filter material instead of felt, polypropylene-clad nose wire instead of aluminum, and nylon-polyurethane ear loops instead of nylon-only.

Testing was conducted per ASTM F2100-19 Level 2, ASTM F2101 (bacterial filtration efficiency), ASTM F3502-25 (submicron particulate filtration), ASTM F1862 (synthetic blood penetration), EN 14683 (breathability/differential pressure), 16 CFR 1610 (flammability), and ISO 10993 standards (biocompatibility including irritation, sensitization, and cytotoxicity).

The KP Protective Face Mask is substantially equivalent to the Techno Web Surgical Mask predicate (K172500) because both devices share the same regulatory class (Class II), product code (FXX), and intended use for surgical personnel protection. Performance testing demonstrates the subject device meets or exceeds all acceptance criteria for filtration efficiency (≥99% BFE, ≥85% PFE), differential pressure, fluid resistance, and biocompatibility, demonstrating equivalent safety and effectiveness to the predicate device.