FDA clears first single-use face mask for children

The US Food and Drug Administration has cleared a face mask designed for children that is made by Kimberly Clark.

The FDA said mask is the first paediatric single-use mask meant for use in hospitals and healthcare facilities to help reduce the spread of airborne respiratory tract bacteria and viruses.

The mask is designed to fit children aged 5–12 years, and is made from material to accommodate children who do not breathe as forcefully as adults.

“Children are not small adults,” said Susan Cummins, chief paediatric medical officer at FDA’s Center for Devices and Radiological Health. “This paediatric face mask helps fill an unmet need for medical devices that are specifically designed for children’s unique anatomy and growing bodies.”

The FDA said performance tests reviewed by the agency showed that airflow 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. Adult supervision of any child wearing a face mask is an important safety recommendation.

The mask should not be used on patients showing signs of shortness of breath, chest pain, chest pressure, in drawing of the lower chest wall, dizziness, or confusion.