The B2 is a reusable respirator that filters 99% of common contaminants and reduces filter cost and waste by half. Unlike existing consumer masks, the B2 features a flexible, patent-pending facepiece that provides superior protection and comfort. The B2 is the culmination of 4+ years of design and development, and is now ready to be mass produced.
Each of these mask types suffers from the following three issues.
Poor face seals: Existing masks don't always achieve an adequate seal on the face, resulting in decreased protectio
High waste and cost: N95 masks are intended to be changed regularly, which is inconvenient and expensive in many use cases
Scalability of manufacturing: Face masks cannot be produced fast enough to meet the demands of both the health care system and general public
The B2 Mask is designed to provide excellent protection to those who are most at risk from airborne contaminants, whether due to increased environmental exposure or preexisting conditions. People who may benefit from improved protection include:
The B2 Mask is not recommended for those who need protection against oil-based particles or chemical vapors.
The B2 Mask addresses the problems with existing masks and offers clear advantages over competitive options. These benefits include:
The B2's patent-pending facepiece provides excellent comfort and protection compared to existing face masks. The facepiece is constructed from FDA-approved materials, folds in half for easy storage, and can accommodate a wide range of face shapes and sizes because of its flex-hinge design.
The B2 Mask uses the latest advances in filter technology that provides 99% filtration against a range of airborne contaminants down to .1 micron.
Particle Filtration Efficiency*: >99.5% at 32 LPM – tested according in accordance to TSI8130 NaCl .1 micron particle size
* Due to supply chain shortages, our 1st generation filters will not include melt-blown polypropylene. This does not compromise filtration level except for extended use in industrial settings. Refer to the following section regarding filter change frequency.
In addition to providing stellar protection, the B2's filters are easy load with a simple twist-to-lock filter cap.
B2 Mask uses the smallest, most affordable high-efficiency filters on the market. During normal use, the B2 filters offer 40-50 hours of protection before filtration efficiency starts to drop. How often you change them filters depends on how you use your B2 Mask. See the recommendations below:
Every B2 comes pre-packaged with 10 filters, or five filter changes (2 filters/change). You can purchase additional filters at the end of the campaign starting at $14 or only $2.30/month for 6 months of protection for standard users.
The B2's filters are small and can be produced more rapidly than N95 masks. This means the B2 can scale to meet the demand of people around the world in search of high-quality breathing protection.
The B2 Mask is designed to provide years of comfortable, sustainable protection. The B2's facepiece is constructed from durable materials and is easy to clean by hand or in a dishwasher. The overlay can be cleaned by hand or in the washing machine for easy maintenance.
The B2 Mask is designed to offer best-in-class protection for daily use. Our team is working with 3rd-party experts to test and validate the two critical facets of mask protection: filtration efficacy and anthropometric fit factor.
We've selected a high-efficiency, electrostatically charged filter media that removes >99% of particulate matter down to .1 micron. The material has been tested for particulate filtration efficiency at Superior Flat and Filtration and at Nelson Labs.
Fit Factor Testing
A well maintained face seal is critical to achieving high levels of protection. Initial tests using the FDA-approved Portacount 8030 system showed the B2 Mask had an average Fit Factor over 100 - the level required for NIOSH certification. Breathe99 is partnering with leading human factors design firm Anthrotech to conduct additional face fit testing with 25 participants that fill the NIOSH panel for face shape and head size
We have designed the B2 Mask to comply with NIOSH N99 standards per 42 CFR Part 84, but the B2 Mask has not yet gone through the regulatory approval process with either NIOSH or the FDA. In the short term, Breathe99 will work to receive through the FDA to receive Emergency Use Authorization (EUA).
Manufacturing & Overmold Complexity While the B2 mask is an incredibly simple product to use, the facepiece involves a complicated overmolding manufacturing process. Our design has been evaluated and approved by material and process experts, and our manufacturing partners are ISO 9001:2015 certified for quality management. Still, this does not eliminate the risks associated with transferring to manufacturing, especially with the speed with which we're trying to move. Regulatory Approval The B2 Mask is not yet FDA or NIOSH approved. We have completed bench testing for all relevant aspects of the B2 Mask, yet there are still risks. We are committed to pursuing all relevant certifications - including N99 certification from NIOSH - but working through these certification processes can take time. In the meantime, Breathe99 will pursue the FDA's Emergency Use Authorization (EUA).
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