Kimberly-Clark Health Care has announced it has received FDA clearance to market its KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity for KC300 to KC600 for pre-vacuum steam and ethylene oxide, according to a news release.
These additional clearances are intended to assist facilities in meeting Joint Commission's sterilization processing guidelines.
"We are the only manufacturer with sterilization wraps that have been validated and FDA cleared for at least 365 days post-sterilization processing shelf-life," said Tom Gonzalez, VP quality assurance & regulatory affairs for Kimberly-Clark Health Care, in the release. "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."
With the most recent FDA clearance for the Amsco V-PRO maX low temperature sterilization system (flexible cycle), the company said the KIMGUARD ONE-STEP sterilization wrap is now FDA cleared for use with all cycles in the three Amsco V-PRO sterilization systems.
Kimberly-Clark Health Care has its North American headquarters in Roswell, Ga.
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