Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce

The Fluidshield 3 surgical and procedure masks are disposable, single-use face masks designed to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These orange, ASTM F2100 Level 3 masks are made of four layers of non-woven materials with optional protective visors and are provided non-sterile for infection control use.

The subject devices are 4-layer masks with the same outer, second, and filter layers as the predicate, but introduce polyethylene or polyester cellulose as alternative inner layer materials (replacing polyester cellulose in the predicate). Additional design options include SO SOFT lining materials, wraparound anti-glare visors, and varied earloop/tie configurations across surgical and procedure mask variants.

ASTM F2100 (face mask performance Level 3), ASTM F2101 (bacterial filtration efficiency), ASTM F2299 (particulate filtration efficiency), ASTM F1862 (fluid resistance), EN 14683 (differential pressure), 16 CFR Part 1610 (flammability), and ISO 10993 series (biocompatibility including cytotoxicity, sensitization, and irritation).

The devices are substantially equivalent because they maintain identical performance specifications to the predicate—both achieve ASTM F2100 Level 3, ≥98% filtration efficiency, 160 mmHg fluid resistance, and pass all biocompatibility tests. The material changes (alternative inner layer polymers) and design variations (visors, SO SOFT options) do not alter the fundamental intended use or safety profile, as demonstrated by non-clinical testing showing equivalent or better performance than the predicate devices.