Ultramasx announces its fan powered KN100 smart mask is registered with the U.S. FDA

Ultramasx announces their flagship product, the Ultramasx UltraOne mask is FDA registered and approved for the general public and healthcare personnel use.

DOVER , DELAWARE , UNITED STATES, January 15, 2021 /EINPresswire.com/ — Ultramasx Technologies, founded in 2019 by award-winning banker and entrepreneur, Ivan Simetovic, aims to address the impacts of global pollution on human health, as well as the impacts of an infectious virus during a worldwide pandemic, with their new technologically advanced electrically ventilated face mask.

Living up to their mission to design the most advanced face mask on earth, Ultramasx recently introduced their new flagship product, the Ultramasx UltraOne. The respirator mask is engineered to not only allow comfortable breathing, but also comfortable wearing, while simultaneously respecting the environment.

The UltraOne offers ‘ultra’ standards

The Ultramasx UltraOne mask is a solution born from various challenges the company found with regular, passive, face masks. The primary challenge was finding a healthy yet comfortable balance between the airflow and filtering capacity of the mask; regular masks that have higher filtering capacities offer lower capacities for fresh airflow. This can be a large cause of discomfort for many people using these face masks.

UltraOne strikes a balance between the filtering capacity and airflow by using a rechargeable 4-stage HEPA (High-efficiency Particulate Air) filter and activated carbon filters with a KN100/N100/FFP3 equivalent rating, including a 2-speed built-in turbofan, which provides up to 6.9 cubic meters of fresh air per hour.

Ultramasx prides itself on having ‘ultra’ standards, the electronic integrations help to circulate the air for healthier breathing while having an “ultra” filtration in place of more than 99.97% of PM 0.3. The mask also focuses on sustainability by using a USB charging port and reusable Ultramax UltraFilters cartridges, it is reusable for years. Last but not least its comfort is superior by using a soft medical-grade face seal and thin straps that do not irritate facial skin.

The UltraOne is not only suitable for protection against pollutants if one is in a larger urban environment, but also for more densely populated areas like airports, especially with the recent COVID-19 pandemic. While the virus particles are smaller in diameter than what anti-pollution masks can filter, the UltraOne is designed in such a way to target these issues to ensure protection beyond just pollution.

FDA Registered

Ultramasx is registered with the U.S. Food and Drug Administration (their operator number is 10079960), and their flagship UltraOne is registered with the listing numbers D432175 and D432516. With this registration, the UltraOne is approved as a respirator and surgical face mask, suitable for use by the general public and healthcare professionals under IIE guidance.

The IIE guidance is an immediately-in-effect policy document, administered by the FDA, stipulating guidelines for clinical laboratories, commercial manufacturers, and Food and Drug Administration personnel about the diagnostics of the COVID-19 virus, as well as increasing the availability of face masks and particulate filtering facepiece respirators suited for healthcare professionals.

Ultramasx’s founder and CEO commends the company’s efforts during this time to get the UltraOne FDA registered, he says, ‘we have been working night and day in the last 12 months, and the U.S. FDA registration is a great milestone for our company. I want to thank all our partners, our team, our suppliers, and above all the customers that helped us improve every day our products’.

The Cadillac of Face Masks

With numerous positive reviews and 5-star Amazon ratings, the UltraOne is touted as the Cadillac of face masks. Featured on media outlets like ABC, NBC, USA Today, Fox News and the New York Post Ultramasx is focused on the future, ‘we are working already on the next generation of smart respirators, that on top of state-of-the-art filtration will also include connectivity. We are close to the American people and families and with this milestone we demonstrate our effort for them’.

For more information on the UltraOne visit the Ultramasx website, with a range of their face mask products, certifications, tutorials, and FAQ.

About UltraMasx

UltraMasx Technologies was founded in 2019 and addresses the impacts of global pollution on human life. The company’s mission is to develop and provide protective and comfortable electronically ventilated face masks for the general public and healthcare professionals, suitable to safeguard against pollution and infectious viruses like the recent COVID-19 pandemic.

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Source: EIN Presswire