FAQ: Breathe99 - B2 Mask
For the most up-to-date information about the status of our project, check our project updates on Indiegogo!

Is B2 Mask FDA or NIOSH certified?

The B2 Mask has been designed to comply with all relevant protection standards per CFR 42 Part 84. The mask has yet to go through regulatory approval, but the Breathe99 team is working quickly to get Emergency Use Authorization through the FDA.

Last updated: August 03, 2020 13:58

What does B2 Mask filter? Does it protect against viruses?

B2 Mask provides excellent protection via an airtight seal and high-efficiency filters that remove >99% of contaminants down to .1 micron during normal breathing rates (similar size as most viruses). However, the mask cannot eliminate the breathing in of all particles and cannot eliminate the possibility of becoming sick. Testing of the filter material was conducted at Superior Felt & Filtration and Nelson Labs.

Last updated: August 03, 2020 13:58

What materials is B2 Mask made of?

B2 Mask features a molded facepiece made from FDA-approved plastics and elastomers. The filters are made from electrostatically charged non-woven polypropylene. The overlay is made from nylon, spandex, and neoprene for comfort and breathability.

Last updated: August 03, 2020 13:58

Does B2 Mask come in different sizes?

The patent-pending hinged facepiece combined with the flexible seal allows the mask to accommodate a wide range of face shapes and sizes. We plan to release a kids size of the mask starting in the summer.

Last updated: August 03, 2020 13:58

Does B2 Mask come in different colors?

B2 Mask’s first production run will be dark grey; however, if we reach our stretch goals we will release several additional colors (August delivery).

Last updated: August 03, 2020 13:58

How often do I need to change my filters?

How often you change them filters depends on how you use your B2 Mask. For typical lifestyle use, we recommend a filter change of once per month. Please refer to the filter buying guide on the campaign for more detail.

Last updated: August 03, 2020 13:58

How do I clean my B2 Mask?

The facepiece is easy to clean by hand or in a dishwasher and the overlay can be cleaned by hand or in the washing machine for easy maintenance.

Last updated: August 03, 2020 13:58

How much is shipping? Are you shipping to all countries?

We estimate shipping costs to be $6 for US/Canada and $14 for most international locations. Breathe99 will make a best effort to ensure B2 Mask is available for shipping to all countries, but we acknowledge that shipping may be impacted due to the pandemic.

Last updated: August 03, 2020 13:58

How does Breathe99’s Give One, Get One model work?

Breathe99 is launching direct to consumer on Kickstarter. For any orders over $75, we will donate an extra B2 Mask to a person in need.

Last updated: August 03, 2020 13:58

Who is eligible to receive a donated mask?

Breathe99 will focus donations toward frontline healthcare workers and those with respiratory conditions who are unable to afford the mask.

Last updated: August 03, 2020 13:58

Where is B2 Mask made?

B2 Mask is made entirely in the US. We work with ISO-certified manufacturers who regularly manufacture medical-grade products and meet the FDA standards for quality.

Last updated: August 03, 2020 13:58

What filtration testing has Breathe99 done?

We’ve are working with the University of Minnesota as a 3rd party independent testing group to validate the B2 Mask’s filter performance. They use lab-grade TSI particle counting equipment to test our samples.

Last updated: August 03, 2020 13:58

What face fit testing has Breathe99 done?

Initial quantitative fit-testing has been performed on several subjects in accordance with the FDA approved Portacount 8038 system. This early bench testing showed B2 Mask achieved a fit factor above 100 during normal motion. Breathe99 is partnering with Anthrotech to conduct additional face fit testing with 25 participants that fill the NIOSH panel for face shape and head size.

Last updated: August 03, 2020 13:58

When will B2 Mask be approved by regulatory bodies?

In the short term, Breathe99 will pursue Emergency Use Authorization from the FDA. NIOSH certification can’t begin until we provide the testing labs with final, manufactured product. Current lead times for NIOSH certification testing is 60 days.

Last updated: August 03, 2020 13:58

Shipping Updates
For the most up-to-date information about the status of our project, check our project updates on Indiegogo!
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