# K133838: Sterilization Pouch/Roll Made with Tyvek

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Medical Supplies Corp.
- Decided: Mar 11, 2015 after 448 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 K921910 (1993). 3 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103210: Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators, Advanced Sterilization Products (2011) Summary page 6.

## Most influential descendants
- K180672: Sterilization Pouch/Roll Made with Tyvek (2018), 9 descendants of its own
- K212198: Tyvek (R) Roll with CI for STERLINKTM Sterilizer (2021), 3 descendants of its own
- K221379: Steriking LT-Blueline Pouches with Tyvek (2023), 1 descendant of its own
- K221377: SteriKing LT-Blueline Pouches with Tyvek (2022), 1 descendant of its own
- K241123: Perpak™ Sterilization Tyvek Pouch (2024), 0 descendants of its own

## Indications for use
The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System. The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types: z Self-sealing sterilization pouches z Sterilization pouches, Flat z Sterilization pouches, Gusseted z Sterilization rolls, Flat z Sterilization rolls, Gusseted

Source page: https://510kreport.com/device/K133838
Methodology: https://510kreport.com/methodology