Vitaform Procedural Mask - Blue (Vitaform Blue); Vitaform Procedural Mask with Shield (Vitaform-FS)

The Vitaform Procedural Mask - Blue and Vitaform Procedural Mask with Shield are single-use, disposable surgical masks intended to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material during medical procedures. The masks feature a fish-shaped design with ear loops and an aluminum nose piece; the shield variant includes an additional polyethylene terephthalate face shield. Both are non-sterile, over-the-counter devices for infection control practices.

Both devices are three-layered masks (spunbond polypropylene outer and inner layers with meltblown polypropylene filter) with PET/Spandex ear loops and aluminum nose pieces. The Vitaform-FS variant adds a thermal-bonded polypropylene insertion layer, an anti-glare polypropylene flap, and a polyethylene terephthalate face shield welded to the upper half. All meet ASTM F2100 Level 3 performance standards. Dimensions differ slightly from predicates (length 215±15mm, width 85±2mm versus predicate dimensions of approximately 172×95mm and 175×89mm).

ASTM F1862 (synthetic blood penetration), ASTM F2101 (bacterial filtration efficiency), ASTM F2299 (particulate filtration efficiency), EN 14683 (differential pressure/airflow resistance), 16 CFR 1610 (flammability), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation). A Predetermined Change Control Plan includes ASTM F3502 for shelf-life aging studies.

The proposed devices meet or exceed the same performance specifications as the predicate devices: both achieve ≥98% particulate and bacterial filtration efficiency, pass fluid resistance at 160 mmHg, maintain differential pressure <6.0 mmH₂O/cm², and are non-cytotoxic, non-irritant, and non-sensitizing. Although the fish-shaped design differs from the flat-pleated predicate geometry, the devices demonstrate equivalent or superior performance across all critical safety and effectiveness parameters, including biocompatibility. The identical product code (FXX) and regulatory classification (Class II, 21 CFR 878.4040) further support substantial equivalence.