ViVi® Toga Premium

The ViVi® Toga Premium is a one-piece head and body surgical gown worn by operating room personnel as part of the ViVi® Surgical Helmet System. It provides a barrier between the operating environment and surgical personnel to protect against contamination and exposure to infectious body fluids and harmful microorganisms. The gown is sterile, disposable, single-use, and sterilized via ethylene oxide.

The device is made of SMS nonwoven with polyethylene film, tested to ANSI/AAMI PB70:2012 Level 4 barrier performance. It uses mechanical slot and hook-and-loop (Velcro®) attachment to the surgical helmet. Available in three sizes (XXS-S, M-L, XL-XXL), it meets the same sterilization assurance level (SAL 10⁻⁶) and biocompatibility standards (ISO 10993-5, 10, 23) as the predicate.

ANSI/AAMI PB70:2012 (liquid barrier), ASTM F2407-06 (surgical gown specification), ASTM F1671 (blood-borne pathogen penetration), ISO 10993 series (biocompatibility), ISO 11810 (laser resistance), ASTM D5587 (tear resistance), ASTM D5034 (tensile strength), ASTM F88 (seam strength), ISO 9073-10 (lint generation), ASTM E96 (water vapor transmission), 16 CFR 1610 (flammability).

The ViVi® Toga Premium is substantially equivalent because it shares the same intended use, device class (II), product code (FYA), regulatory classification (surgical apparel), and materials (SMS nonwoven with PE film) as the predicate TotalShield™ II Zippered Surgical Toga. Both devices achieve identical barrier performance (Level 4 compliant), sterilization methods (ethylene oxide, SAL 10⁻⁶), and biocompatibility endpoints. Nonclinical testing demonstrates the subject device performs as well as or better than the predicate across all measured properties (flammability, tear resistance, tensile strength, seam strength, laser resistance, linting, and water vapor transmission).