Single-use face mask approved for children
The FDA has cleared a face mask designed specifically for children to be worn in hospitals and health care facilities to help reduce the spread of airborne pathogens, according to an FDA press release.
The Kimberly-Clark Pediatric/Child Face Mask is specially designed to fit children aged 5 to 12 years and includes specific fitting instructions for the adult who assists the child in using the device.
Children are not small adults, said Susan Cummins, MD, chief pediatric medical officer at the FDAs Center for Devices and Radiological Health. This pediatric face mask helps fill an unmet need for medical devices that are specifically designed for childrens unique anatomy and growing bodies.
Performance tests reviewed by the FDA showed that air flow and filtering ability of the mask were appropriate for children. The mask should not be used on patients showing signs of shortness of breath, chest pain, chest pressure, indrawing of the lower chest wall, dizziness or confusion.
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