# K243179: Sterilization Pouch and Roll

- Pathway: 510(k) (Traditional)
- Applicant: Yichang Xinxin Paper Products Co., Ltd.
- Decided: Jun 26, 2025 after 269 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 7.

## Indications for use
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows: • Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time. The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch’s external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization. Table of Maximum Load

Source page: https://510kreport.com/device/K243179
Methodology: https://510kreport.com/methodology