# K123162: U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll

- Pathway: 510(k) (Traditional)
- Applicant: U&U Medical Technology Co, Ltd.
- Decided: Feb 26, 2014 after 505 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: 2 generations back to K921910 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103210: Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with Sterrad Chemical Indicators, Advanced Sterilization Products (2011) Summary page 1.

## Indications for use
U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch / Roil are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD I100NX Hydrogen Peroxide Gas Plasma sterilizer. The recommended Hydrogen Peroxide Gas Plasma cycle parameter: STERRAD IOGONX STANDARD Cycle Sterilization load claim: STERRAD IOONIX Sterilizer Standard cycle: -General medical instruments (metal and nonmetal, including hinged devices) -Instruments with single-channel stainless steel lumens with an Internal diameter 3mm or larger and length 150 mm or shorter. - Polyethylene and Teflon lumen tubing with an Internal diameter of 3 mm or larger and length of 500 mm or shorter. * These items must be sterilized without any additional load items - Limit of 20 pieces of tubing per cycle Load condition: One device per Sterilization Pouch. Load chamber Two shelves (total weight: 21.4 lbs or 9.7 kg) Load Pouch: Leave enough malarial beyond the seal for the opener to easily grasp (usually 1-1 'A Inches). SHELF UFE: It Is recommended that the products are put to their end use withln 2 years of manufacture. The recommended "best before data and the manufacturing date are stated on the label. This device was demonstrated to maintain sterility of the contents for 30 days after Sterilization.

Source page: https://510kreport.com/device/K123162
Methodology: https://510kreport.com/methodology