# K212338: SterileRight sterilization pouch and roll

- Pathway: 510(k) (Traditional)
- Applicant: Sterileright Packaging Mfg., Inc.
- Decided: Nov 1, 2021 after 97 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: 5 generations back to K990567 (1999). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102158: Sigma Sterilization Pouch & Roll, Sigma Medical Supplies Corp. (2011) Summary page 5.

## Most influential descendants
- K221875: Sterilization Pouch and Roll (2023), 3 descendants of its own
- K251347: Sterilization Pouch/Roll (2026), 0 descendants of its own
- K251177: Self-Seal Sterilization Pouch and Roll (2025), 0 descendants of its own
- K241565: Sterilization Package/Reel (2025), 0 descendants of its own
- K242898: Sterilization Pouches and Reels (2025), 0 descendants of its own

## Indications for use
The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: * Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. * Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. * Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film. The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. 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 SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

Source page: https://510kreport.com/device/K212338
Methodology: https://510kreport.com/methodology