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CROSSTEX Self-Sealing Sterilization Pouch

by Cross Country Paper Products Corp.

510(k) K941327

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941327 Date22 Dec 1994ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1791-2022 FDA Class III initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KCT
Device Class
Class II
Regulation
21 CFR Part 880.6850
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CROSSTEX Self-Sealing Sterilization Pouch is a sterile barrier system designed for packaging medical devices prior to sterilization. It provides a sealed environment to protect instruments and devices from contamination during sterilization processes, such as steam or ethylene oxide, while ensuring sterility is maintained until use. Constructed from medical-grade paper, the pouch features self-sealing properties to prevent recontamination upon opening. Its design includes structural reinforcements like chevron patterns and corner tack seals to enhance integrity and prevent breaching during handling.

This pouch is intended for single-use and is supplied in sterile condition, ready for loading with medical instruments or devices prior to sterilization. It is classified under FDA product code KCT (Sterilization Pouches) and holds a 510(k) clearance (K941327) for substantial equivalence to predicate devices. The pouch is not MRI-safe or intended for reuse; it must be discarded after a single use to maintain sterility. Storage should follow manufacturer guidelines to preserve barrier integrity, and it is compatible with standard sterilization methods approved for medical-grade paper.

Other devices from Cross Country Paper Products Corp.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CROSSTEX Self-Sealing Sterilization Pouch used for?

    The CROSSTEX Self-Sealing Sterilization Pouch is designed as a sterile barrier system for packaging medical devices before sterilization. It creates a sealed environment to shield instruments from contamination during processes like steam or ethylene oxide sterilization, ensuring sterility is preserved until the device is ready for use. The pouch’s reinforced structure—including chevron patterns and corner tack seals—helps maintain integrity during handling and sterilization.

  • How is the CROSSTEX Self-Sealing Sterilization Pouch supplied, and is it sterile?

    The pouch is supplied in a sterile condition, ready for immediate use. It is intended for single-use only, meaning it should be discarded after one use to uphold sterility standards. The sterile barrier is maintained through its self-sealing properties, which prevent recontamination once opened.

  • Can the CROSSTEX Self-Sealing Sterilization Pouch be reused?

    No, the pouch is explicitly designed for single-use only. Reusing it compromises sterility and the integrity of the barrier system, which could expose medical devices to contamination. The manufacturer’s guidelines emphasize disposal after one use to ensure compliance with sterilization protocols.

  • What sterilization methods is the pouch compatible with?

    The pouch is compatible with standard sterilization methods approved for medical-grade paper, including steam sterilization and ethylene oxide sterilization. Its construction ensures it can withstand these processes without compromising the protective barrier or the sterility of the packaged devices.

  • How should the CROSSTEX Self-Sealing Sterilization Pouch be stored?

    Storage should follow the manufacturer’s guidelines to preserve the pouch’s barrier integrity. This typically involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the pouch remains effective for its intended single-use application and maintains its sterility until use.