← Back to catalogue

Tyvek Sterilization Pouches with Chevron Seal

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152058

by Andersen Sterilizers, Inc.

Identifiers

510(k) Number
K152058 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 Tyvek Sterilization Pouches with Chevron Seal are sterile barrier systems designed to protect medical devices during sterilization and storage. These pouches provide a reliable containment solution for single-pouch sterilization processes, ensuring microbial integrity and preventing contamination of enclosed items.

These pouches are intended for use in healthcare facilities, specifically within a 12-hour sterilization cycle at temperatures between 20–29°C. Supplied as single-use items, they are compatible with ethylene oxide gas sterilization systems and offer a puncture-resistant barrier. Authorized under FDA 510(k) clearance (K152058), they adhere to regulatory standards for sterilization packaging.

Frequently asked questions

Are these pouches reusable, or are they meant for single-use only? Why does that matter for sterilization?

These pouches are single-use only, as explicitly stated in the description. Reusing them risks compromising the sterile barrier, which is critical for preventing microbial contamination of enclosed medical devices. The puncture-resistant design and ethylene oxide compatibility are optimized for one-time use within a 12-hour sterilization cycle, ensuring consistent protection and regulatory compliance.

What temperature range should these pouches be stored in before use, and why is that important?

The pouches are designed for use within a temperature range of 20–29°C during sterilization, though storage conditions aren’t explicitly detailed here. Maintaining this range during sterilization ensures the integrity of the Tyvek material and the effectiveness of the ethylene oxide process, as extreme temperatures could degrade the pouch’s barrier properties or alter its sealing performance.

Are these pouches compatible with any specific sterilization methods, and how do I confirm they’re properly sealed?

These pouches are specifically designed for ethylene oxide gas sterilization systems and are not intended for other methods like autoclaving or gamma irradiation. The chevron seal design provides a visual indicator of proper sealing—if the chevron pattern is intact and unbroken, the pouch is likely sealed correctly. Always verify the seal before use to ensure microbial integrity.

What size options are available for these pouches, and how do I know which one fits my medical devices?

The specifications provided do not list explicit size options (e.g., small, medium, large), so you’ll need to refer to Andersen Sterilizers’ product catalog or technical documentation for dimensions. Since these pouches are for single-pouch sterilization, selecting the right size ensures proper containment without overstuffing, which could compromise the sterile barrier or sealing integrity.

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: Tyvek Sterilization Pouches with Chevron Seal by Andersen Sterilizers ..., Tyvek Sterilization Pouches with Chevron Seal, Self-Sealing Tyvek® Steam Sterilization Pouch With Chevron Peel

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Andersen Sterilizers, Inc.

Sources (1)

  • FDA 510(k) K152058 24 fields · synced Sep 19, 2026