# K221875: Sterilization Pouch and Roll

- Pathway: 510(k) (Traditional)
- Applicant: Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
- Decided: Feb 13, 2023 after 230 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.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212338: SterileRight sterilization pouch and roll, Sterileright Packaging Mfg., Inc. (2021) Summary page 6.

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

## Indications for use
The 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: • Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. • Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C (131°F) and 40% to 90% relative humidity for 6 hour. Aeration time of 7 days at 20°C). The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintains the sterility of the enclosed devices for up to 24 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 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. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.

Source page: https://510kreport.com/device/K221875
Methodology: https://510kreport.com/methodology