Baltimore-based ClearMask LLC, a privately held medical supply company consisting of Johns Hopkins University graduate students and alumni, has received an initial OK from the U.S. Food and Drug Administration for what the company calls the first fully transparent, surgical-grade face mask.
The FDA clearance — officially known as 510(k) clearance — is a premarket approval that the mask is safe and effective.
ClearMask says the mask can be used in hospitals and clinics, as well as schools, retail, hospitality and other settings.
In addition to blocking particles or droplets, the fully transparent, anti-fog plastic mask helps improve visual communication, the mask-maker 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,” said Allysa Dittmar, president of ClearMask.
The company’s website says, “See the person, not the mask.”
ClearMask already produces a nonmedical, consumer version of the transparent mask, which can be purchased starting at $67 for a box of 24 masks.
The company has partnered with several distributors, including Cardinal Health Canada, McKesson, Oaktree Products and Grainger.
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