ClearMask introduces world's first CE-marked, fully transparent surgical mask
PR91947
BALTIMORE, Sept. 29, 2021 /PRNewswire=KYODO JBN/ --
-- Fully transparent, anti-fog masks available in the European Union to provide
clear communication and safety for healthcare providers and essential workers
ClearMask LLC, a privately held American medical supply company, announced
today that its ClearMask(TM) is the world's first and only fully transparent
surgical mask that is both CE-marked and FDA-cleared. To date, no other
transparent masks meet both certifications.
Photo -
https://mma.prnewswire.com/media/1632666/EZ_Adjuster_ClearMask_transparent_mask__FDA_approved.jpg
The ClearMask(TM) transparent surgical masks meet the CE Marking requirements
as a Class I medical device under the European Union Medical Device
Regulation (2017/745) and can be used in hospitals, clinics, schools, and other
settings. The mask is optimized for maximum clarity and comfort, meeting
applicable EN 14683 requirements for fluid resistance, microbial cleanliness,
and biocompatibility, which offers a high level of protection for medical use
in environments such as operating rooms.
In the United States, the ClearMask(TM) brand received FDA clearance as a Class
II medical device (https://c212.net/c/link/?t=0&l=en&o=3300045-1&h=177583116&u=https%3A%2F%2Fwww.accessdata.fda.gov%2Fcdrh_docs%2Fpdf20%2FK200576.pdf&a=FDA+clearance+as+a+Class+II+medical+device) on April 6, 2020, and meets
applicable ASTM Level 3 requirements in the United States for fluid resistance and flammability.
The ClearMask(TM) transparent surgical mask also passed additional tests in accordance with the
transparent mask guidelines released by the United Kingdom, including tests for resistance
to penetration of microorganisms (ASTM F1671) and visibility (EN 166).
During the pandemic, the ClearMask(TM) brand has helped provide protection
against the transfer of aerosols, fluids, and sprays, and has been widely
adopted as the new standard to help improve communication and trust where masks
are required. With its fully transparent, anti-fog plastic barrier, the
ClearMask(TM) brand increases visual communication, which may help avoid costly
errors and adverse outcomes. As demonstrated in a first-of-its-kind study in
the Journal of the American Medical Association (https://c212.net/c/link/?t=0&l=en&o=3300045-1&h=3784622576&u=https%3A%2F%2Fjamanetwork.com%2Fjournals%2Fjamasurgery%2Ffullarticle%2F2777511&a=Journal+of+the+American+Medical+Association), the ClearMask(TM) is also critical in establishing rapport and earning
trust.
The company started developing the transparent mask in 2017 after their deaf
co-founder suffered an adverse experience during her surgery. Traditional
surgical masks blocked her providers' faces, impeding effective communication
and essential safety checks.
"When the pandemic began, our mission was to bring a human-centered mask to
everyone who needed it, especially children, older adults, deaf and hard of
hearing people, and those who heavily depend on visual communication. ClearMask
continues to fight against the current pandemic and we are here to stay," said
Allysa Dittmar, President of ClearMask.
To date, the company has provided over 18 million masks in the United States
and globally. The company has partnered with several distributors, including
Cardinal Health, Grainger, Henry Schein, McKesson, and Oaktree Products, and is
currently onboarding (https://c212.net/c/link/?t=0&l=en&o=3300045-1&h=2711807134&u=https%3A%2F%2Fwww.theclearmask.com%2Fdistributor-form&a=currently+onboarding) distributors for the CE-marked masks. The masks can be purchased in the
United States through ClearMask's website at www.buy.theclearmask.com, and
countries outside the United States may purchase the masks here (https://c212.net/c/link/?t=0&l=en&o=3300045-1&h=8915224&u=https%3A%2F%2Fsupport.theclearmask.com%2Fhc%2Fen-us%2Fcategories%2F360005419732-International&a=here).
About ClearMask ClearMask, LLC is an American-based medical supply company that
focuses on improving communication while making connections more human. Its
products may help reduce errors and increase satisfaction by facilitating
visual communication for all. For more information, please visit
www.theclearmask.com.
Media Contact:
ClearMask, LLC
E-mail: press@theclearmask.com
Download Logo (https://c212.net/c/link/?t=0&l=en&o=3300045-1&h=456625470&u=https%3A%2F%2Fwww.theclearmask.com%2Fs%2FClearMask_logo&a=Download+Logo)
Download Photo (https://c212.net/c/link/?t=0&l=en&o=3300045-1&h=1853525178&u=https%3A%2F%2Fwww.theclearmask.com%2Fs%2FClearMask_photo&a=Download+Photo)
Available Languages
SOURCE ClearMask
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