# K143637: U&U Sterilization Pouch and Roll

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Sep 9, 2015 after 261 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.
4 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)
- K102158: Sigma Sterilization Pouch & Roll, Sigma Medical Supplies Corp. (2011) Summary page 6.

## Most influential descendants
- K162258: Self Sealing Sterilization Pouches (2017), 1 descendant of its own
- K182184: Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) (2019), 0 descendants of its own
- K183356: Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch (2019), 0 descendants of its own
- K181957: Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted (2019), 0 descendants of its own

## Indications for use
The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121° C. The recommended EtO sterilization cycle is 4 hours at 55° C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90 Days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. STERILIZATION CYCLE: The recommended gravity steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes. Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55°C (130 °F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85% RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C Sterilization load claim: Two types of sterilization loads were validated. Load A: Metal medical instruments and Hand-control pen, the total weight is 24lbs. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs.

Source page: https://510kreport.com/device/K143637
Methodology: https://510kreport.com/methodology