# K233262: Dukal SMS Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Dukal, LLC
- Decided: Mar 22, 2024 after 175 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: 3 generations back to K881471 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
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 7.
- K143053: KIMGUARD ONE-STEP Sterilization Wrap, Kimberly-Clark Health Care (2015) Summary page 7.

## Indications for use
The Dukal SMS sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: * In a steam sterilization pre-vacuum cycle at 270°F / 132°C for 4 minutes 0 Models 100, 200 and 300 were validated for dry times of 20 minutes; models 400, 500 and 600 were validated for dry times of 30 minutes. * In 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. o The wrap was validated for aeration times for EO sterilization of 16 hours at 40.0°C. Dukal SMS sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) for 6 months or until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps. Test results validated that the Dukal SMS sterilization wraps allowed sterilization of the enclosed medical device(s) by ethylene oxide sterilization and by pre-vacuum cycles. These models of the Dukal SMS sterilization wrap have been validated for use with the ethylene oxide and pre-vacuum cycles listed in below table:

Source page: https://510kreport.com/device/K233262
Methodology: https://510kreport.com/methodology