Kimberly-Clark receives FDA clearance for all ASP STERRAD System modalities
KIMGUARD family of sterilisation wrap is the most validated sterilisation wrap on the US market
Kimberly-Clark is the first and only manufacturer to receive 510(k) clearance from the US 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 sterilisation modalities: STERRAD Sterilization Systems, Pre-vacuum Steam, Ethylene Oxide (EO) and Amsco V-Pro.
'Surgical sterilisation 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 sterilisation 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 sterilisation wrap is the most validated sterilisation wrap on the US market with comprehensive FDA clearance for use with the following sterilisation 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 | |
| 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 sterilisation 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 sterilisation system, this new update will help ensure the safest possible environment for patients and their families, healthcare workers, providers and communities.'
