Kimberly-Clark Sterilization Wrap Receives FDA Clearance for All ASP STERRAD System Modalities

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Kimberly-Clark announces that it is the first and only manufacturer to receive 510(k) clearance from the 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.  
 
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,” says Steve Camp, vice president of regulatory and clinical affairs for 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
o Standard Cycle
o FLEX Cycle
o EXPRESS Cycle
o DUO Cycle
• STERRAD®NX® System
o Standard Cycle
o Advanced Cycle
• STERRAD®100S System
• STERRAD®200 System
• STERRAD®50 System
Pre-vacuum Steam
Ethylene Oxide (EO)
Amsco® V-PRO
• 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,” says Anthony Bishop, vice president of global marketing for 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.”

Source: Kimberly-Clark Health Care

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