Kimberly-Clark Health Care has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the KIMGUARD ONE-STEP portfolio with 1-year maintenance-of-package integrity (MPI) for KC300 to KC600 for pre-vacuum steam and ethylene oxide (EO).
With the most recent FDA clearance for Amsco V-PRO maX low temperature sterilization system (Flexible Cycle), the KIMGUARD ONE-STEP sterilization wrap is now FDA cleared for use with all cycles in the three Amsco V-PRO sterilization systems. With this announcement, KIMGUARD sterilization wrap has the most 510(k) clearances than any other sterilization wrap including use with:
- Pre-vacuum steam—up to 1 year MPI
- Ethylene oxide (EO)—up to 1 year MPI
- Amsco V-PRO maX (V-PRO lumen, non-lumen, and flexible cycles)
- Amsco V-PRO 1 Plus (V-PRO lumen and non-lumen cycles)
- Amsco V-PRO 1 (V-PRO lumen cycle)
Kimberly-Clark has also completed testing that supports use of KIMGUARD ONE-STEP sterilization wrap with additional low temperature sterilization systems. This data has been submitted to the FDA for acceptance.
Source: Kimberly-Clark Health Care