ROSWELL, Ga., Sept. 5, 2013 /PRNewswire/ -- Kimberly-Clark announced today that it is the first and only manufacturer to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of the KIMGUARD ONE-STEP Sterilization Wrap portfolio with all Advanced Sterilization Products (ASP) STERRAD® Systems, including the new DUO Cycle for the STERRAD® 100NX® System.
As always, users can continue to have confidence that their instruments wrapped with KIMGUARD ONE-STEP Sterilization Wrap, which includes KIMGUARD ONE-STEP Quick Check, will maintain sterility of the enclosed medical instruments until used. The ONE-STEP Sterilization Wrap is cleared for use with all major sterilization modalities: STERRAD® Sterilization Systems, Pre-vacuum Steam, Ethylene Oxide (EO) and Amsco® V-Pro.
"Surgical sterilization technology is rapidly evolving and, as an innovator in the market, we have worked closely with ASP and FDA to obtain clearance of the KIMGUARD ONE-STEP Sterilization Wrap now qualified for use with all STERRAD Systems," said Steve Camp, Vice President, Regulatory and Clinical Affairs, Kimberly-Clark Health Care. "Thorough testing and evaluation of the KIMGUARD family of Sterilization Wrap products with all available sterilization processing modalities are paramount to sterility assurance. Kimberly-Clark is pleased to provide clinicians with this added assurance of sterility of their instruments supporting their mission of delivering excellent patient care."
KIMGUARD Sterilization Wrap meets the most rigorous industry standards for safety and performance, including resistance to fire, abrasion, and microbial contamination, to maintain the sterility of instruments. The KIMGUARD ONE-STEP family of sterilization wrap is the most validated sterilization wrap on the U.S. market with comprehensive FDA clearance for use with the following sterilization modalities:
STERRAD® Sterilization Systems
- STERRAD® 100 NX® System
- Standard Cycle
- FLEX Cycle
- EXPRESS Cycle
- DUO Cycle
- STERRAD® NX® System
- Standard Cycle
- Advanced Cycle
- STERRAD® 100S System
- STERRAD® 200 System
- STERRAD® 50 System
Ethylene Oxide (EO)
- maX (V-PRO Lumen, Non Lumen, and Flexible Cycles)
- 1 Plus (V-PRO Lumen and Non Lumen Cycles)
- 1 (V-PRO Lumen Cycle)
"Advanced Sterilization Products' STERRAD® Systems represents the largest installed base of hydrogen peroxide sterilization systems throughout the world," said Anthony Bishop, Vice President, Global Marketing, ASP. "With the growing importance of having the manufacturers' instructions for use (IFUs) support the sterilization system, this new update will help ensure the safest possible environment for patients and their families, healthcare workers, providers and communities."
Kimberly-Clark Corp. (NYSE: KMB) and its well-known global brands are an indispensable part of life for people in more than 175 countries. Every day, nearly a quarter of the world's population trust K-C's brands and the solutions they provide to enhance their health, hygiene and well-being. With brands such as Kleenex, Scott, Huggies, Pull-Ups, Kotex and Depend, Kimberly-Clark holds the No. 1 or No. 2 share position in more than 80 countries. To keep up with the latest K-C news and to learn more about the Company's 141-year history of innovation, visit www.kimberly-clark.com or follow us on Facebook or Twitter.
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 their patients and staff. As part of their healing mission, caregivers rely on Kimberly-Clark to deliver clinical solutions, hygiene & cleaning offerings, and educational resources that they can depend on to prevent, diagnose and manage a wide variety of healthcare-associated infections. A global enterprise of more than $1 billion, Kimberly-Clark Health Care holds the No. 1 or No. 2 market share position in several categories, including infection control solutions, surgical solutions, pain management, hygiene solutions, digestive health and respiratory health. And throughout the care continuum, patients and staff alike trust Kimberly-Clark medical supplies and devices, KLEENEX tissues, KLEENEX & SCOTT skin care products and SCOTT towels for day-to-day needs. For more information, visit http://www.kchealthcare.com and http://www.kcprofessional.com. [KMB-B]
SOURCE Kimberly-Clark Corporation