FDA clears KCHC pediatric face mask

2 October 2011 (Last Updated October 2nd, 2011 18:30)

Kimberly-Clark Health Care (KCHC) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its pediatric face mask.

Kimberly-Clark Health Care (KCHC) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its pediatric face mask.

The child's face mask is a single-use device intended to be worn by children aged five to 12 to provide protection for the respiratory tract. It has been specifically designed to fit small faces to maximise effectiveness and compliance.

The decision by KCHC to undertake the 510(k) regulatory submission pathway for the child's face mask was in response to a call for action from the Society for Healthcare Epidemiology of America, the Association for Professionals in Infection Control and Epidemiology and the Association of PeriOperative Registered Nurses.