Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user’s face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user’s face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.
Both models comprise four layers of material: an outer layer of spun-bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bound polypropylene.
All of the construction materials used in this 510(k) device are typical construction materials commonly used in surgical face masks and being used in current legally marketed devices. Not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions.
The face mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the face mask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and equine influenza viruses.
RespoKare line of face masks, including the first Anti-Viral Child's Mask cleared by the U.S. Food and Drug Administration fore the indicated use of inactivating 99.99% of viruses quickly, and is the only mask technology available globally with this language currently, plus FDA cleared.
The human coronavirus 229E (a non lethal lab testing surrogate for the corona viruses unsealing SARS, MERS and COVID-19) was inactivated by >99.99% in one minute, based on third-party testing reports submitted to FDA.
BF-200-3015A and BF-2002005A are a single use, disposable device that inactivates 99.9% of viruses in seconds, a huge improvement over ordinary masks, and is currently the only mask cleared by the FDA for inactivating COVID-19 in seconds.
So important we had to say it twice, BF-200-3015A and BF-2002005A are designed to inactivate 99.9% of viruses in seconds. The outer layer traps contaminated droplets, the active layer inactivates pathogens, the filter layer traps fine particles and the inner layer is water resistant for more protection.
The Anti-viral layer is a rayon material treated with something that mimics sialic acid, commonly found on the surface of human cells. Virus is trapped in this layer, exposed to small but highly localized concentrations of copper and zinc ions, and is destroyed.
The anti-viral coatings are formulated from a combination of commonly used food additives recognized as safe by the US and EU regulatory agencies.
The Anti-Viral Mask is laboratory tested and US FDA cleared for inactivating 99.99% of the influenza viruses within 5 minutes when in contact with the outer layer of the mask.
Everyone knows, if the mask doesn't fit right, the child will never wear it correctly. The Anti-Viral Face Masks for kids is sized correctly for kids (ages 5-10).