# K112300: Kimguard Smart-Fold* Sterilization Wrap

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Jan 19, 2012 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). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082177: Kimguard One-Step Sterilization Wrap, Kimberly-Clark Corp. (2009) Summary page 3.

## Most influential descendants
- K140963: Kimguard Smart-Fold Sterilization Wrap (2014), 0 descendants of its own

## Indications for use
KimGuard Smart-Fold* 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 2700 F/1 32CC for 4 minutes or by 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131 OF/ 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 EQ sterilization of 8 hours at 131OF/155 0C or 12 hours at 110 0'F/ 43.30 C. The KimGuard Smart-Fold t Sterilization Wrap was validated for dry times for pre-vacuum steam sterilization of 20 minutes for Model K0250 and for dry times of 30 minutes for Models KC450, KC550 and KC650. See Wrap Model Recommendations on Page 2.

Source page: https://510kreport.com/device/K112300
Methodology: https://510kreport.com/methodology