HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

The HALYARD FLUIDSHIELD 3 Fog-Free Procedure Mask is a four-layer surgical mask designed to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material during medical procedures. Available in two versions—one with earloops and one with earloops plus a WrapAround Visor—these are single-use, disposable, nonsterile devices intended for infection control practices.

Both subject and predicate devices are Class II surgical masks (21 CFR 878.4040, Product Code FXX) with similar four-layer nonwoven construction, earloops, and malleable nosepieces. Key differences include the inner layer composition (subject uses Polyethylene Terephthalate/Polyethylene BICO versus predicate's White Polyester Cellulose), slight color variations in outer/second layers (Blue and White Polypropylene Spunbond versus Orange), and addition of a 5-year shelf life specification. Design dimensions, ultrasonic bonding, and ASTM F2100 Level 3 performance are substantially similar.

ASTM F2100 (Level 3), ASTM F2101 (Bacterial Filtration Efficiency ≥98%), ASTM F2299 (Particulate Filtration Efficiency ≥98%), EN 14683 (Differential Pressure <6.0 mmH2O/cm²), ASTM F1862 (Fluid Resistance 160 mmHg), 16 CFR Part 1610 (Flammability Class 1), ISO 11737-1 (Microbial Cleanliness ≤30 cfu/g), and ISO 10993 series (Biocompatibility: Systemic Toxicity, Sensitization, Irritation, and Cytotoxicity).

The subject device is substantially equivalent to the predicate KC300 Procedure Face Masks (K111402) because both devices share the same FDA classification, regulatory code, intended use, and overall design as four-layer surgical masks for infection control. All performance testing demonstrated acceptance criteria were met, including passage of ASTM F2100 Level 3 and biocompatibility standards identical to the predicate, establishing that the subject device is as safe, effective, and performs as well as or better than the legally marketed predicate device.