Kimberly-Clark’s Pediatric Face Mask Becomes First to Receive FDA Clearance

Kimberly-Clark Health Care, Roswell, Ga, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Kimberly-Clark Child’s Face Mask. This marks the first time the FDA has granted any manufacturer 510(k) clearance for a pediatric face mask and gives the products a Class II medical device designation.

The pediatric face mask is a single-use device, intended for children ages 5-12 to provide protection for the respiratory tract of children who may be at increased risk for infection in health care settings such as waiting rooms and exam rooms..

The mask has been designed to fit small faces and features Disney characters on its outer-facing panel.

Source: Kimberly-Clark Health Care