ClearMask™ is the world’s first FDA-cleared, fully transparent surgical mask suitable for 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 protect while bringing much-needed relief through a reassuring smile and familiar face among fear and 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,” according to ClearMask.
To meet the rigorous controls necessary for FDA-cleared products, ClearMask LLC and Xometry, the largest marketplace for On-Demand manufacturing partnered with PKG Inc., an ISO 13485-certified facility, to manufacture the FDA-cleared version of the ClearMask™. PKG will provide valuable experience in building FDA-approved products, enabling mass production while achieving rigorous oversight and high quality.
This November, PKG Inc. officially kick-started a new production floor designed to meet the mass production of the FDA-cleared ClearMask™, which has been in high demand.