# K082177: Kimguard One-Step Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Mar 27, 2009 after 238 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: 1 generation back to K881471 (1988). 1 ancestor in all.
44 later devices descend from it; 9 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881471: Kimguard (Regular & Heavy Duty) Sterile Wrap, Kimberly-Clark Corp. (1988) Summary page 2.

## Most influential descendants
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600 (2009), 35 descendants of its own
- K091685: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC 500, KC600 (2009), 32 descendants of its own
- K112805: Kimguard One-Step Sterilization Wrap (2012), 18 descendants of its own
- K112211: Dura Blue Sterilization Wrap (2011), 11 descendants of its own
- K112918: Durablue Sterilization (Amsco V-Pro) Wrap (2012), 10 descendants of its own

## Indications for use
KIMGUARD ONE-STEP* Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by pre-vacuum steam at 270°F/132 0C for 4 minutes or by.100% ethylene oxide (EtO) with a concentration of 725-735 mg/L at 131 F/ 550C and 40% - 80% relative humidity for 60 minutes. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until opened. The wrap was validated for aeration times for EO sterilization of 8 hours at 55 0C or 12 hours at 43.3 0C. The wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Models 100 and 200, and for 30 minutes for Models 400, 500, and 600. KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for gravity steam sterilization. *The KC300 Model KIMGUARD ONE-STEP* Sterilization Wrap is not indicated for use for pre-vacuum steam sterilization. See Wrap Model Recommendations on Page 2.

Source page: https://510kreport.com/device/K082177
Methodology: https://510kreport.com/methodology