The FDA granted Kimberly-Clark Health Care the first 510(k) clearance for a single-use pediatric face mask.
Designated as a Class II medical device, the colorful mask is used to protect the respiratory tracts of children ages five to 12 from various bacteria, viruses and pathogens. It’s intended for use in waiting rooms and hospitals, to protect already immuno-compromised children from further infection
"Children are not small adults," said Susan Cummins, the FDA’s chief pediatric medical officer, in prepared remarks. "This pediatric face mask helps fill an unmet need for medical devices that are specifically designed for children’s unique anatomy and growing bodies."
In addition to being sized properly for kids, the mask was designed to be less resistant to airflow than adult masks, because children don’t breath as forcefully as adults.
"Children are among our most vulnerable patients, and product design that reflects their unique physical and emotional characteristics can make a significant difference in our collective efforts to reduce the spread of infection," said Kimberly-Clark Health Care’s General Manager Jay Hexamer in prepared remarks.
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