Several leading healthcare organizations have issued a joint statement to express their support for FDA's recent decision to grant 510(k) clearance to a new pediatric mask developed by Kimberly-Clark Health Care.
The joint statement (pdf) comes from the Society for Healthcare Epidemiology of America, Association for Professionals in Infection Control and Epidemiology, Pediatric Infectious Diseases Society and the Association of periOperative Registered Nurses.
The clearance is the first time FDA has granted any manufacturer 510(k) clearance for a pediatric face mask. 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.
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According to the joint statement, "As pediatric healthcare workers who provide care for children, as well as manage their infection prevention, the groups urged KCHC and other manufacturers to seek formal FDA clearance and validation of their pediatric surgical face mask in preventing droplet particle spread, the chief way influenza and other respiratory pathogens are transmitted.
"The groups hope the FDA clearance of KCHC's Child's Face Mask leads the way for inclusion of pediatric face masks into the Strategic National Stockpile, a pre-determined national supply of medicines and medical supplies which are available to be dispensed to healthcare facilities and communities in the event of a national public health crisis."
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