ClearMask announced today that it received FDA 510(k) clearance for its ClearMask fully transparent surgical mask for use in a number of settings.
Baltimore-based ClearMask touts its surgical mask as the first FDA-cleared fully transparent surgical mask for use in hospitals, clinics, schools, retail, hospitality and other settings.
The company said in a news release that the mask meets requirements for fluid resistance and flammability, offering protection for medical use in settings such as an operating room. Additionally, the transparent mask with an anti-fog plastic barrier helps to improve visual communication.
Clearance for the ClearMask could also come at a timely moment as healthcare providers and other frontline workers require protection amid the COVID-19 pandemic. The company has partnered with several distributors to get the masks to as many people who need it as possible, with partners including Cardinal Health Canada, McKesson, Oaktree Products and Grainger.
“After three years of research, development, and testing, we are thrilled to bring a human-centered mask to everyone who needs it, especially those who can benefit from improved visual communication, such as children, older adults, deaf and hard of hearing people, and those who do not speak the same language,” ClearMask president Allysa Dittmar said in the release. “The ClearMask is well-positioned to join the fight against the current pandemic.”
“Regulatory clearance and mass production are two significant milestones in ClearMask’s mission to get the ClearMask out to as many people as possible,” ClearMask CEO Aaron Hsu added. “This achievement is a testament to our company’s hard work and commitment to serving different communities in need during this time.”