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 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.
For more information, visit www.kchealthcare.com.