Medical supply company ClearMask has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its fully transparent surgical mask.
ClearMask is claimed to be the world’s first FDA-cleared and fully transparent surgical mask, which is suitable for use in hospitals, clinics, schools, retail, hospitality, and other settings.
The new surgical mask will help provide maximum clarity and comfort
The company has designed the new anti-fog mask to provide maximum clarity and comfort, as well as meet applicable ASTM Level 3 requirements for fluid resistance and flammability, thereby enabling to provide advanced protection for medical use in environments such as operating rooms.
ClearMask enables to enhance visual communication to avoid costly errors and adverse outcomes, in addition to blocking particles or droplets with its fully transparent and anti-fog plastic barrier.
ClearMask president Allysa Dittmar said: “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. The ClearMask is well-positioned to join the fight against the current pandemic.”
ClearMask is said to be the first product in the company’s growing portfolio of novel masks to secure FDA clearance as a Class II medical device.
The company also stated that it is currently providing a non-medical and consumer face mask, which similarly helps to enhance visual communication and provide protection at a lower price.
The consumer masks are suitable for use in different communities, including state emergency management agencies and essential workers.
ClearMask has collaborated with various distributors such as Cardinal Health Canada, McKesson, Oaktree Products, and Grainger for efficient supply of masks.
ClearMask CEO Aaron Hsu said: “Regulatory clearance and mass production are two significant milestones in ClearMask’s mission to get the ClearMask out to as many people as possible.”
In July this year, UK government announced the acceleration of face mask production with 10 new manufacturing sites.
