FDA clears way for world’s first fully transparent surgical mask

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ClearMask LLC, a privately held American medical supply company, announced that it received the U.S. FDA 510(k) clearance 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.

“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,” said Allysa Dittmar, President of ClearMask.

The ClearMask™ is the first product in ClearMask LLC’s growing portfolio of novel masks to receive FDA clearance as a Class II medical device. To fulfill the current and rising demand as the company ramps up production of the FDA-cleared mask, the company is currently offering a non-medical, consumer face mask that similarly helps to improve visual communication and provide protection at a lower price. The consumer masks have provided much relief to different communities in need, including state emergency management agencies and essential workers.

To date, the company has provided the masks in bulk volumes, typically in the tens to hundreds of thousands. The consumer masks can now be purchased through ClearMask’s website at buy.theclearmask.com, starting at a box of 24 masks. The company has partnered with several distributors, including Cardinal Health Canada, McKesson, Oaktree Products, and Grainger to help get the masks out to as many people as possible.

“Regulatory clearance and mass production are two significant milestones in ClearMask’s mission to get the ClearMask out to as many people as possible,” said Aaron Hsu, CEO of ClearMask. “This achievement is a testament to our company’s hard work and commitment to serving different communities in need during this time.”