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Kimberly-Clark Health Care Receives FDA Clearance For KIMGUARD ONE-STEP Sterilization Wrap Portfolio With One-Year Maintenance Of Package Integrity And Amsco V-PRO maX (Flexible Cycle)
Date:7/12/2012

ROSWELL, Ga., July 12, 2012 /PRNewswire/ -- Kimberly-Clark Health Care announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity (MPI) for KC300 to KC600 for Pre-vacuum Steam and Ethylene Oxide (EO). Users can now have confidence that their instruments wrapped with KIMGUARD ONE-STEP Sterilization Wrap will maintain sterility on the shelf for at least 365 days.

The KIMGUARD family of sterilization wrap is now the most validated sterilization wrap with the longest shelf-life on the U.S. market. These additional clearances will assist facilities in complying with The Joint Commission's sterilization processing guidelines.

"We are the only manufacturer with sterilization wraps that has been validated and FDA cleared for at least 365 days post-sterilization processing shelf-life. In fact, KIMGUARD ONE-STEP shelf-life is currently 12 times longer than any other sterilization wrap's shelf-life that has been previously cleared and marketed. This is especially significant for surgical trays that aren't used on a regular basis," said Tom Gonzalez, VP Quality Assurance & Regulatory Affairs, Kimberly-Clark Health Care.

"The extensive testing conducted to obtain MPI one-year 510(k) clearance illustrates Kimberly-Clark's commitment to providing our customers with sterilization solutions that meet their needs while offering the optimum balance of properties including lint and flame resistance, and high bacterial filtration efficiency (BFE), to provide our customers with confidence in sterility," added Mr. Gonzalez.

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
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SOURCE Kimberly-Clark Health Care
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