# K202462: SIGMA Sterilization Pouch and Roll

- Pathway: 510(k) (Abbreviated)
- Applicant: Sigma Medical Supplies Corporation
- Decided: Apr 23, 2021 after 239 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: 6 generations back to K990567 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180661: SIGMA Sterilization Pouch and Roll, Sigma Medical Supplies Corp. (2018) Summary page 5.

## 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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: * Gravity steam at 121'C (250 0 F) for 30 minutes; Drying time of 30 minutes. * Gravity steam at 132 0 C (270oF) for 15 minutes; Drying time of 30 minutes. * Gravity steam at 135 0 C (275 0 F) for 10 minutes; Drying time of 30 minutes. * Pre-vacuum steam at 132 0 C (270'F) for 4 minutes; Drying time of 20 minutes. * Pre-vacuum steam at 135'C (2750 F) for 3 minutes; Drying time of 16 minutes. * EO sterilization cycle is 4 hours at 55 0 C (131'F) with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam 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 6 types: * Self-sealing sterilization pouches * Self-sealing sterilization multi pouches * Sterilization pouches, Flat * Sterilization pouches, Gusseted * Sterilization rolls, Flat * Sterilization rolls, Gusseted

Source page: https://510kreport.com/device/K202462
Methodology: https://510kreport.com/methodology