Kimberly-Clark Health Care (KCHC) announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market the Kimberly-Clark Child’s Face Mask. This marks the first time that the 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 decision by KCHC to undertake the 510(k) regulatory submission pathway for the Child’s Face Mask was in response to a call for action from the Society for Healthcare Epidemiology of America (SHEA), the Association for Professionals in Infection Control and Epidemiology (APIC) and the Association of PeriOperative Registered Nurses (AORN). Those organizations and the FDA were important contributors in defining key considerations that shaped product design and recommended ages for use. KCHC worked with the FDA to develop standardized clinical measurements that are specific to the unique circumstances of pediatric mask use and performance in healthcare settings.

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, and has been specifically designed to fit small faces to maximize effectiveness, comfort and compliance. Featuring colorful Disney characters on its outer-facing panel to create familiarity and appeal, the mask is intended for use in healthcare settings such as waiting areas and exam rooms to protect children who may be at increased risk for infection. These include children who are already ill, immuno-compromised, displaying flu-like symptoms, potentially contagious while visiting a patient family member, or having a routine check-up during flu season or a pandemic outbreak. According to the Centers for Disease Control and Prevention (CDC), even patients with undiagnosed respiratory symptoms should be asked to wear a face mask in the waiting room.

“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,” says Jay Hexamer, general manager, North America Medical Supplies, Kimberly-Clark Health Care. “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.”

“Children are not small adults,” adds Susan Cummins, chief pediatric medical officer in the FDA’s device division. “This pediatric face mask helps fill an unmet need for medical devices that are specifically designed for children’s unique anatomy and growing bodies.”

The FDA says performance tests reviewed by the agency showed that air flow and filtering ability of the mask were appropriate for children. The mask includes specific fitting instructions for the adult who assists the child in using the device.