The first face mask intended for use on children has been approved by the US Food and Drug Administration.
The first face mask intended for use on children has been approved by the US Food and Drug Administration (FDA).
The purpose of the Kimberly-Clark Pediatric/Child Face Mask—which is designed to fit children between the ages of five and 12 years old—is to help reduce the spread of airborne respiratory tract bacteria, viruses, and other pathogens, as it is meant to be worn in hospitals and health care facilities.
The FDA reported in a news release that the face mask is less resistant to airflow than an adult mask, as children (specifically children with respiratory infections) do not breathe as powerfully as adults.
“Children are not small adults,” reported Susan Cummins, MD, chief pediatric medical officer at FDA’s Center for Devices and Radiological Health. “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 reviewed performance tests which showed that air flow and the filtering ability of the mask were suitable for children and cleared the product on September 23, 2011.
The mask comes with instructions for the adult who assists the child in using the product with precise fitting instructions. The FDA stressed that a vital safety recommendation is for adult supervision of all children donning a face mask.
Further, the agency stated that the mask should not be used on child patients presenting with signs of shortness of breath, chest pain, chest pressure, indrawing of the lower chest wall, dizziness, or confusion.