The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer’s face.
A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.