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U&U Sterilization Pouch and Roll

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143637

by U&U Medical Technology Co, Ltd.

Identifiers

510(k) Number
K143637 FDA 510(k)
FDA Product Code
FRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The U&U Sterilization Pouch and Roll is a sterilization wrap designed to enclose medical devices for terminal sterilization. Classified under product code FRG, it is intended for use with hydrogen peroxide gas plasma sterilization systems, such as the STERRAD 100NX. Constructed as a protective barrier, it ensures devices remain isolated and uncontaminated during the sterilization process, maintaining sterility until use. Its design adheres to regulatory standards for medical sterilization packaging, providing a reliable containment solution for healthcare settings.

Supplied as a single-use item, the pouch and roll are intended for use in General Hospital environments. They are not reusable and must be discarded after one sterilization cycle to prevent cross-contamination. The device is sterile upon packaging and requires no additional preparation beyond proper sealing before sterilization. Storage should follow manufacturer guidelines to preserve integrity, and compatibility is confirmed for use with STERRAD 100NX hydrogen peroxide gas plasma sterilizers. The product holds FDA 510(k) clearance (K143637) under the Substantially Equivalent (SESE) determination, classified as a Class II medical device under regulation 880.6850.

Frequently asked questions

Are these sterilization pouches meant for reuse in multiple sterilization cycles, or are they single-use only?

These U&U Sterilization Pouches and Rolls are explicitly designed as single-use items. They must be discarded after one sterilization cycle to prevent cross-contamination and ensure sterility integrity. The manufacturer emphasizes this to maintain compliance with sterilization protocols and avoid compromising the protective barrier.

What types of sterilization systems are these pouches compatible with, and do they require any special preparation before use?

The U&U Sterilization Pouch and Roll is specifically designed for hydrogen peroxide gas plasma sterilization systems, such as the STERRAD 100NX. No additional preparation is required beyond properly sealing the pouch before sterilization—it is sterile upon packaging and ready for use as-is. Compatibility is confirmed for these systems only.

How should these pouches be stored to ensure they remain intact and functional until use?

While the exact storage guidelines aren’t detailed in the data, the pouch’s integrity must be preserved to maintain sterility and barrier protection. The manufacturer recommends adhering to their published storage instructions (not provided here) to avoid damage from moisture, heat, or physical stress. Improper storage could compromise the pouch’s ability to protect devices during sterilization.

Are these pouches suitable for use in all types of healthcare facilities, or are they tailored to specific environments?

These pouches are intended for General Hospital environments, as indicated by their advisory committee classification (HO). While they may be used in other settings, their design and regulatory filing align with standard hospital sterilization workflows, particularly those employing hydrogen peroxide gas plasma systems like the STERRAD 100NX.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: U&U Sterilization Pouch and Roll (K143637) — FDA 510 (k) | Innolitics, U&U Sterilization Pouch And Roll 510(k) K143637 - FDA.report, U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/Roll

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
U&U Medical Technology Co, Ltd.

Sources (1)

  • FDA 510(k) K143637 24 fields · synced Sep 20, 2026