Kimberly-Clark Sterilization Receives 510(k) Clearance (OR Today)
Kimberly-Clark Health Care, soon to be Halyard Health, has announced that it is the first and only manufacturer to receive 510(k) clearance from the U.S. Food and Drug Administration for use of its sterilization wrap portfolio with all standard sterilization modalities.
The Kimguard One-Step and Quick Check family of sterilization wrap is the most validated sterilization wrap on the U.S. market, with comprehensive FDA clearance for use with all of the following sterilization modalities:
• STERRAD Sterilization Systems
* STERRAD 100NX
* STERRAD NX
* STERRAD 100S
* STERRAD 200
* STARRAD 50
• STERIS Sterilization Systems
* STERIS V-PRO 1
* STERIS V-PRO 1 Plus
* STERIS V-PRO maX
· Pre-vacuum Steam
· Ethylene Oxide (EO)
· Gravity Steam
“Providing innovation in sterilization technology has been a longtime priority at Kimberly-Clark Health Care and we will continue to invest in innovation as we transition to Halyard Health,” said Lon Taylor, Marketing Director, Surgical and Infection Prevention, Kimberly-Clark Health Care. “Securing FDA clearance for use of our market-leading sterilization wrap with each and every sterilization modality supports our ongoing mission to help clinicians prevent infections and protect patients.”
The Kimberly-Clark sterilization wrap portfolio includes innovations such as Quick Check Wrap, the first dual-color wrap in the U.S. market, and Smart-Fold, a new type of sterilization wrap designed to be 3 times more tear-resistant and twice as fast to use as conventional wrap.
In November 2014, Kimberly-Clark Health Care will become Halyard Health, an independent medical technology company focused on preventing infection, eliminating pain and speeding recovery.