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FDA clears first single-use children's face mask

by Brendon Nafziger, DOTmed News Associate Editor | September 30, 2011
Credit: Kimberly-Clark
The Food and Drug Administration gave 510(k) clearance to the first single-use, medical face mask designed specifically for children, after nurses and infection control specialists called on the industry to get FDA review for such products.

The mask, developed by Kimberly-Clark, was cleared Sept. 23, and it's primarily intended to protect children aged five to 12 from airborne pathogens when they're in the hospital or other health care settings. It's also meant for sick, and potentially contagious, children to wear when visiting a family member in the hospital.

The FDA said children, especially sick ones, can't breathe as forcefully as adults, so the mask allows more airflow than an adult mask.

"Children are not small adults," said Dr. Susan Cummins, chief pediatric medical officer at the FDA's Center for Devices and Radiological Health, in a statement. "This pediatric face mask helps fill an unmet need for medical devices that are specifically designed for children's unique anatomy and growing bodies."

However, the FDA also noted that the mask is not intended for children with "shortness of breath, chest pain, chest pressure, indrawing of the lower chest wall, dizziness, or confusion."

Roswell, Ga.-based Kimberly-Clark said the face mask features Disney characters on the outside to create "familiarity and appeal."

In a joint statement, the Society for Healthcare Epidemiology of America, the Pediatric Infectious Diseases Society, the Association for Professionals in Infection Control and Epidemiology and the Association of PeriOperative Registered Nurses, all welcomed the new product clearance.

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