# K143053: KIMGUARD ONE-STEP Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Health Care
- Decided: Apr 3, 2015 after 162 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881471 (1988). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082554: Kimguard Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500 and KC600, Kimberly-Clark Corp. (2009) Summary page 5.
- K082177: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2009) Summary page 5.

## Most influential descendants
- K233262: Dukal SMS Sterilization Wrap (2024), 0 descendants of its own

## Indications for use
KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: * Pre-vacuum steam at 270°F / 132°C for 4 minutes. The wrap was validated for dry times of 20 minutes for models KC100 and KC200. * 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131°F / 55°C and 40-80% relative humidity for 60 minutes. The wrap was validated for aeration times for EO sterilization of 8 hours at 55°C or 12 hours at 43.3°C for models KC100 and KC200. KIMGUARD* ONE-STEP* Sterilization Wrap (KC100, KC200) are intended to allow sterilization of the enclosed medical device(s) and also maintain sterility of the enclosed device(s) until used. Test results validated that KIMGUARD* ONE-STEP* Sterilization Wraps (KC100, KC200) allowed sterilization of the enclosed devices by the ethylene oxide sterilization and by pre-vacuum cycles. These models of the KIMGUARD* ONE-STEP* Sterilization Wrap have been validated for use with the ethylene oxide and pre-vacuum cycles in Table 1 (see page 2 of 2)

Source page: https://510kreport.com/device/K143053
Methodology: https://510kreport.com/methodology