The clearance is the first time FDA has granted any manufacturer 510(k) clearance for a pediatric face mask and establishes the product with the designation of a Class II medical device.
The Kimberly-Clark Child’s Face Mask is a single-use device that is intended to be worn by children ages 5-12 to provide protection for the respiratory tract. It has been designed to fit small faces and features Disney characters on its outer-facing panel.
“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 Jay Hexamer, general manager, North America medical supplies, Kimberly-Clark Health Care, in the release. “Kimberly-Clark Health Care is proud to have received this landmark regulatory clearance for our pediatric face mask, and greatly appreciates the critical input and guidance we have received from our customers, the clinical community and the FDA.”
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