FDA Clears Kimberly Clark’s Kimguard One-Step Sterilisation Wrap Portfolio With One-Year Package Integrity

In short

Kimberly-Clark Health Care has announced that it has received FDA 510(k) clearance for its KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity for KC300 to KC600 for Pre-vacuum Steam and Ethylene Oxide.

The company says users can now have confidence that their instruments will maintain sterility on the shelf for at least 365 days.


KIMGUARD ONE-STEP Sterilization Wrap consists of two layers of wrap thermally sealed along the sides to provide protection of double-wrapping in one step. This feature cuts the wrapping and unwrapping time in half compared to sequential wrapping, saving valuable time in Sterile Processing, as well as sterility assurance in the operating room. The most recent addition to the KIMGUARD ONE-STEP Wrap portfolio, QUICK CHECK Sterilisation Wrap, securely joins a blue wrap layer with a white layer so users can quickly and easily identify if sterility has been breached – ensuring patient safety. In addition, Kimberly Clark says KIMGUARD Sterilisation Wrap, manufactured in the US, features POWERGUARD Technology which it claims provides superior protection against contamination, making it one of the best microbial barriers available.

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

Company comments

“We are the only manufacturer with sterilization wraps that has been validated and FDA cleared for at least 365 days post-sterilisation processing shelf-life. In fact, KIMGUARD ONE-STEP shelf-life is currently 12 times longer than any other sterilisation 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 sterilisation 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.

Source: Kimberly Clark