Navigation Links
Kimberly-Clark Health Care Receives Landmark FDA Clearance for Pediatric Face Mask

ROSWELL, Ga., Sept. 28, 2011 /PRNewswire/ -- Kimberly-Clark Health Care (KCHC) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market the Kimberly-Clark Child's Face Mask. This marks the first time that the FDA has granted any manufacturer 510(k) clearance for a pediatric face mask and establishes the product with the designation of a Class II medical device.


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 (SHEA), the Association for Professionals in Infection Control and Epidemiology (APIC) and the Association of PeriOperative Registered Nurses (AORN). Those organizations and the FDA were important contributors in defining key considerations that shaped product design and recommended ages for use. KCHC worked with the FDA to develop standardized clinical measurements that are specific to the unique circumstances of pediatric mask use and performance in healthcare settings.

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, and has been specifically designed to fit small faces to maximize effectiveness, comfort and compliance. Featuring colorful Disney characters on its outer-facing panel to create familiarity and appeal, the mask is intended for use in healthcare settings such as waiting areas and exam rooms to protect children who may be at increased risk for infection. These include children who are already ill, immuno-compromised, displaying flu-like symptoms, potentially contagious while visiting a patient family member, or having a routine check-up during flu season or a pandemic outbreak. According to the Centers for Disease Control and Prevention (CDC), even patients with undiagnosed respiratory symptoms should be asked to wear a face mask in the waiting room.

"Children are among our most vulnerable patients, and product design that reflects their unique physical and emotional characteristics can make a significant difference in our collective efforts to reduce the spread of infection," said Jay Hexamer, General Manager, North America Medical Supplies, Kimberly-Clark Health Care. "Kimberly-Clark Health Care is proud to have received this landmark regulatory clearance for our pediatric face mask, and greatly appreciates the critical input and guidance we have received from our customers, the clinical community and the FDA."

Kimberly-Clark in the Healthcare Environment

Around the world, medical professionals turn to Kimberly-Clark for a wide portfolio of solutions that improve the health, hygiene and well -being of patients and hospital staff. As part of their healing mission, caregivers rely on Kimberly-Clark to deliver clinical solutions and educational resources that they can depend on to prevent, diagnose and manage a wide variety of healthcare-associated infections. As a global enterprise with more than $1 billion in annual sales, Kimberly-Clark Health care holds the No. 1 and No. 2 market share positions in several categories including; infection control solutions, surgical solutions, pain management and digestive health. Throughout the care continuum, patients and staff alike trust Kimberly-Clark medical supplies and devices, KLEENEX tissues, Kimberly-Clark Professional skin care products and SCOTT towels for day-to-day needs. For more information, please visit

SOURCE Kimberly-Clark Health Care
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Kimberly-Clark Health Care Announces Selling Price Increase
2. Kimberly-Clark Launches KimVent Multi-Access Port Closed Suction System
3. Kimberly-Clark Health Care Presents an OR-Liveā„¢ Premiere Webcast - Endoscopic Placement Method of Balloon-Retained Feeding Tubes
4. Kimberly-Clark Health Care Announces Strategic Green Partnerships, Commitment to Reducing Medical Waste
5. Kimberly-Clark Corporation Selects Promax as its North America Trade Promotion Management and Optimization Solution Provider
6. Kimberly-Clark Acquires Baylis Medical Companys Pain Management Business
7. Visual Healthcare to Supply Enabling Technology for Home Care Consortium Software and Support Revenues to Reach $17 M in Phase One
8. Aging-in-Place Research Breakthroughs To Be Presented At Wireless Health 2011 Conference
9. Americans Favor Investment in Community and Home-Based Health Care, According to Harris Interactive Survey, September 2011
10. UCLA Health System - Jonsson Comprehensive Cancer Center to Acquire ViewRay Radiation Therapy Research System
11. Brain Resource Launches MyCalmBeat Personal Stress Reduction Monitor at Health 2.0
Post Your Comments:
(Date:11/26/2015)... North Carolina , 26 november 2015 ... Inc. (AAIPharma/CML) kondigt de geplande investering aan ... uitbreiding van de laboratoria en het mondiale ... . De uitbreiding zal resulteren in extra ... wordt voldaan aan de groeiende behoeften van ...
(Date:11/26/2015)... and Markets ( ) has announced the addition of ... - Rise in Cardiac Disorders and Growing Awareness among People ... Boston scientific and others. ... others. --> The market is dominated by ... scientific and others. Asia ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Testing Market: Supplier Shares, Competitive Intelligence, ... --> ) has ... Future Horizons and Growth Strategies in ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, from Hopkinsville, ... prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. , The ... medications. In doing so, it could help to prevent potential overdose situations. As ...
(Date:11/27/2015)... ... , ... ProSidebar: Fashion is a set of 30 kinetic edge ... video editors can easily add an informative sidebar to any FCPX production. Create ... featuring self-animating drop zones, lines, bars, and text with the ease of FCPX's drag ...
(Date:11/27/2015)... ... ... A simply groundbreaking television series, "Voices in America", which is hosted by ... of issues that are presently affecting Americans. Dedicated to providing the world with a ... the subjects consumers focus on, one episode at a time. , In the ...
(Date:11/27/2015)... ... 27, 2015 , ... The men and women on this ... in the country. They have overseen financial turnarounds, shown commitment to their community ... industry as a whole through their advocacy and professional efforts. , Becker's Hospital ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point ... come together on Thanksgiving Day to share the things that they are most ... Serenity Point YouTube channel, patients displayed what they wrote on index cards, describing ...
Breaking Medicine News(10 mins):