3B Products Receives Emergency Clearance from FDA for N95 Sanitation

WINTER HAVEN, Fla. (December 7, 2020)—3B Medical announced today receiving Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic. Lumin was designed to clean CPAP accessories but is also used as a multi-purpose sanitizer. Today’s announcement by the FDA allows Lumin to be used by health care workers employed in nursing homes, long term acute care, ambulatory, primary care, and clinics to allow N95 re-use to stop the spread of COVID-19 and help keep frontline health care workers safe.

UVC was first reportedly used for N95 decontamination during the COVID-19 crisis by the University of Nebraska Medical Center. Since then the CDC recognized UVC as a potential means of decontaminating N95 respirators, if the proper wavelength and UVC irradiance dose were used. While FDA has approved other systems for hospital use, the approved systems are complicated, limited to large hospitals and/or extremely expensive. Lumin is the only N95 decontamination system formally recognized by FDA for killing SARS-CoV-2 that can be purchased for under $300, and with a small enough footprint to be used safely in small offices and clinics, as well as in nursing homes.

“The COVID-19 pandemic requires novel approaches and thinking outside the box. We were starting to get inundated with calls from hospitals and nursing homes asking if Lumin was strong enough to kill SARS-CoV-2. Lumin’s total output in a single five-minute cycle ranges up to 2,400 mJ/cm2, which studies show is sufficient to kill almost any pathogen, including SARS-CoV-2. A lot of the calls coming into our office are from fire departments, nursing homes and smaller community hospitals, clinics and primary care physician offices trying to keep their workers safe. Lumin is likely the only device designed for home use that is powered high enough to repurpose for this use. We are very excited to have our device authorized by FDA for this application”, said Alex Lucio, CEO of 3B Medical, Inc.

N95 mask shortages have been widely reported throughout the country, and globally. “Being able to re-use an N95 mask quickly and effortlessly is a game changer for allowing healthcare workers to remain safe. Front line healthcare workers are in dire need of an immediate solution to re-use their masks. Lumin is fast and easy to use and we are glad the device could be re-purposed to meet that need in this crisis,” said Lucio.

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