# K242898: Sterilization Pouches and Reels

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Jianzhong Medical Packaging Co., Ltd.
- Decided: Feb 21, 2025 after 151 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: 7 generations back to K990567 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221875: Sterilization Pouch and Roll, Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. (2023) Summary page 7.

## Indications for use
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows: a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20°C (68 °F). The Sterilization Pouches and Reels is composed of medical grade paper and medical compound film, maintains the sterility of the enclosed devices for up to 12 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 indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization process. Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g) The following tables (Table 1~5) identifies the size of subject device and its Maximum validated load.

Source page: https://510kreport.com/device/K242898
Methodology: https://510kreport.com/methodology