# K102158: Sigma Sterilization Pouch & Roll

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Medical Supplies Corp.
- Decided: Aug 2, 2011 after 368 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: 4 generations back to K990567 (1999). 4 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070428: Medicom Self-Sealing Sterilization Pouch, A.R. Medicom, Inc. (2007) Summary page 2.
- K051242: Winner Self Seal Sterilization Pouch, Winner Medical (Usa), Inc. (2005) Summary page 7.

## Most influential descendants
- K212338: SterileRight sterilization pouch and roll (2021), 5 descendants of its own
- K143637: U&U Sterilization Pouch and Roll (2015), 4 descendants of its own
- K221875: Sterilization Pouch and Roll (2023), 3 descendants of its own
- K180661: SIGMA Sterilization Pouch and Roll (2018), 2 descendants of its own
- K162258: Self Sealing Sterilization Pouches (2017), 1 descendant of its own

## Indications for use
The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121tC. The recommended EO sterilization cycle is 4 hours at 551C with a relative humidity between 50O/o 85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process. The SIGMA sterilization pouch and roll is offered in the following 5 types: * Self-sealing sterilization pouches * Sterilization pouches, Flat * Sterilization pouches, Gusseted * Sterilization rolls, Flat * Sterilization rolls, Gusseted

Source page: https://510kreport.com/device/K102158
Methodology: https://510kreport.com/methodology