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FDA NEWS RELEASE

For Immediate Release: Sept. 28, 2011
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA clears first single use face mask for children

The U.S. Food and Drug Administration has cleared the Kimberly-Clark Pediatric/Child Face Mask, designed to be worn in hospitals and health care facilities to help reduce the spread of airborne respiratory tract bacteria, viruses, and other pathogens.

The mask is designed to fit children ages 5 years to 12 years. Children do not breathe as forcefully as adults, particularly children with respiratory infections, so the face mask is less resistant to airflow than an adult mask.

“Children are not small adults,” said Susan Cummins, M.D., 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.”

Performance tests reviewed by the FDA showed that air flow and filtering ability of the mask were appropriate for children. The mask, cleared on Sept. 23, 2011, 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, indrawing of the lower chest wall, dizziness, or confusion.

Kimberly-Clark Corp. is based in Dallas.
For more information:
FDA: Medical Devices

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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