BALTIMORE, Md. — ClearMask LLC, a privately held American medical supply company, announced Friday that it received the U.S. Food and Drug Administration’s 510(k) clearance on April 6, 2020, for its ClearMask™, a fully transparent surgical mask.
ClearMask™ is the world’s first FDA-cleared, fully transparent surgical mask that can be used in hospitals, clinics, schools, retail, hospitality, and other settings. The mask is optimized for maximum clarity and comfort, and meets applicable ASTM Level 3 requirements for fluid resistance and flammability, which offers a high level of protection for medical use in environments such as operating rooms.
In this disheartening time as the world fights against the COVID-19 pandemic, the ClearMask™ helps provide protection while bringing much-needed relief through a reassuring smile and familiar face among fear, confusion, and suffering. In addition to blocking particles or droplets with its fully transparent, anti-fog plastic barrier, the ClearMask™ helps improve visual communication, which may help avoid costly errors and adverse outcomes. Transparent communication during the customer experience can be critical in establishing rapport and earning trust, while assuring safety as a priority.
The company, consisting of Johns Hopkins University graduate students and alumni, started developing the transparent mask in 2017 after their deaf co-founder experienced an adverse experience during her surgery. Traditional surgical masks blocked her providers’ faces, impeding effective communication and safety.