Medical version of the surgical mask gets FDA approval
One of the major drawbacks of a face mask is that it hides the wearer’s smile.
Baltimore-based ClearMask LLC has solved that problem by developing a transparent mask that reveals a person’s facial expressions and visual cues while still blocking droplets and particles. This week the company announced that it has received initial approval from the Food and Drug Administration for the medical-grade version of its surgical mask.
The FDA’s 501(k) clearance allows the company to manufacture the masks.
“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,” Allysa Dittmar, president of ClearMask, stated in a news release.
Besides health care organizations, the privately held company envisions schools, stores and hotels making use of the masks.
The medical version of the ClearMask offers ASTM Level 3 fluid protection for heavy levels of aerosols, spray and/or fluids that health care workers are likely to encounter. All ClearMasks are designed to be fog-proof.
The mask was devised by graduate students and alumni of Johns Hopkins University after the company’s deaf co-founder experienced the frustration of being unable to communicate with doctors and nurses after her surgery.
The company sells its non-medical mask in a box of 24 masks at a reduced price. It says it has been bought by state emergency management agencies and other essential emergency workers.