To meet the rigorous controls necessary for FDA-cleared products, ClearMask and Xometry, the largest marketplace for On-Demand manufacturing, partnered with PKG, an ISO 13485-certified facility, to manufacture the FDA-cleared version of the ClearMask
The first fully transparent, FDA-cleared mask produced in the US is made possible through a manufacturing partnership between ClearMask, Xometry, and PKG. (Credit: Business Wire)
Cerebain Biotech announced that PKG is to become the key manufacturer for ClearMask, LLC and Xometry.
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,” announced ClearMask in its press release.
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.
Over the next few weeks, PKG Inc. intends to fully transition company ownership to Cerebain Biotech Corporation in an acquisition that began in the middle of this year. Upon completion, under the Cerebain Biotech umbrella, PKG Inc. will continue its support in mass-producing large volumes of the FDA-cleared ClearMask™. Almir Garibovic stated “We are proud to help ClearMask fight against the pandemic with a smile on our face that everyone can see. All of us are looking forward to successfully providing innovative accessibility and protection to a diverse population.”
Source: Company Press Release