BALTIMORE – ClearMask, LLC, a privately-held U.S. medical supply company, today announced that its ClearMask ™ mask is the world’s first and only fully transparent surgical mask with CE certification and FDA approval . To date, no other transparent mask meets the requirements of these two certifications.
ClearMask ™ transparent surgical masks meet CE marking standards 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 environments. The mask is designed to provide optimized clarity and comfort, meeting the applicable requirements of EN 14683 for liquid resistance, microbial cleanliness and biocompatibility. This standard provides a high level of protection for medical applications in environments such as operating theaters.
In the United States, the ClearMask ™ brand received FDA approval as a Class II medical device on April 6, 2020 and meets the applicable requirements of the ASTM Level 3 standard in the United States for resistance to liquids and flammability. The ClearMask ™ Clear Surgical Mask has also successfully passed other tests in accordance with UK guidelines for clear masks, including testing for Resistance to Penetration by Microorganisms (ASTM F1671) and visibility (EN 166).
During the pandemic, the ClearMask ™ brand has helped provide protection against the dispersion of aerosols, liquids and sprays and has been widely adopted as a new standard to improve communication and trust in demanding environments. wearing masks. With its completely transparent plastic anti-fog barrier, the ClearMask ™ brand improves visual communication, helping to avoid costly mistakes and negative repercussions. As demonstrated in a groundbreaking study published in the Journal of the American Medical Association , the ClearMask ™ mask also promotes patient bonding and trust.
La société a commencé la mise au point du masque transparent en 2017 à la suite d’une expérience négative dont a fait l’objet sa co-fondatrice, atteinte de surdité, lors d’une intervention chirurgicale. Les masques chirurgicaux traditionnels bloquaient le visage des prestataires de soins, entravant la communication efficace et les contrôles de sécurité essentiels.
“When the pandemic began, our mission was to offer a user-centered mask to anyone who needed it, including children, the elderly, the deaf and hard of hearing, as well as users who support mainly on visual communication. ClearMask continues to fight the current pandemic and does not intend to stop its efforts, ”said Allysa Dittmar , president of ClearMask.
To date, the company has supplied more than 18 million masks in the United States and around the world. It has partnered with several distributors, including Cardinal Health, Grainger, Henry Schein, McKesson and Oaktree Products, and is in the process of recruiting distributors for its CE certified masks.
About ClearMask: ClearMask, LLC is a United States-based medical supplies company with a mission to improve communication while making relationships more human. Its products can help reduce errors and increase satisfaction by facilitating visual communication for all.