Kimguard One-Step Sterilization Wrap
by Kimberly-Clark Health Care 510(k)
Active
510(k) K142782
Overview
The Kimguard One-Step Sterilization Wrap is a medical device designed to enclose other medical devices during the sterilization process. It is constructed from two sheets of SMS material, providing six layers of protection that act as a barrier to bacteria and liquids while allowing for the penetration of sterilants.
This wrap is intended for use with pre-vacuum steam sterilization at 270°F/132°C or 100% ethylene oxide sterilization. The product is available in six grades ranging from KC100 to KC600 and has received FDA 510(k) clearance. It is designed for use by health care providers to maintain the sterility of enclosed instruments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142782 | Date9 Mar 2015 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6850
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kimberly-Clark Health Care
Questions
What sterilization methods are compatible with Kimguard One-Step wraps?
These wraps are designed for use with pre-vacuum steam sterilization at 270°F/132°C or 100% ethylene oxide sterilization. This ensures that the barrier material allows for the necessary penetration of sterilants while maintaining the integrity of the enclosed instruments.
How is the Kimguard One-Step wrap constructed?
The wrap is constructed from two sheets of SMS material bonded together. This design provides six total layers of protection that act as a barrier against bacteria and liquids, helping to maintain the sterility of the enclosed medical devices.
What are the available grades for this sterilization wrap?
The product is available in six distinct grades, ranging from KC100 to KC600. These variations allow healthcare providers to select the appropriate level of protection required for their specific sterilization needs.