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Guardian Sterilization Wrap

by Kimberly-Clark Corp. 510(k)

Active United States

510(k) K803294

Overview

The Guardian Sterilization Wrap is a sterilization wrap designed to protect medical instruments and supplies during sterilization and storage. It is classified under product code FRG and serves as a barrier to maintain sterility, preventing contamination from external sources. Constructed from nonwoven fabric, it ensures a secure seal to preserve the sterile environment of packaged items.

This wrap is intended for use in general hospital settings, where it is applied to instruments or supplies prior to sterilization processes such as steam or ethylene oxide sterilization. Supplied as a single-use item, it adheres to FDA clearance (K803294) under a Traditional 510(k) review, ensuring compliance with regulatory standards. Available in standard sizes, it requires proper storage in a clean, dry environment to maintain integrity before use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK803294 Date2 Feb 1981ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the Guardian Sterilization Wrap used for?

    The Guardian Sterilization Wrap is designed as a protective barrier to shield medical instruments and supplies from contamination during sterilization and storage. It ensures a sterile environment by creating a secure seal around packaged items, making it ideal for use in general hospital settings before steam or ethylene oxide sterilization processes.

  • Is the Guardian Sterilization Wrap reusable or single-use?

    The Guardian Sterilization Wrap is explicitly intended for single-use only. After one sterilization cycle, the wrap should be discarded to prevent cross-contamination and maintain compliance with sterile processing protocols.

  • How should the Guardian Sterilization Wrap be stored before use?

    To preserve its integrity, the wrap must be stored in a clean, dry environment away from direct sunlight or moisture. Proper storage ensures the nonwoven fabric remains free of dust, debris, or humidity, which could compromise its ability to form a reliable seal during sterilization.

  • What sterilization methods can the Guardian Sterilization Wrap be used with?

    This wrap is compatible with both steam sterilization and ethylene oxide sterilization processes. Its nonwoven construction is designed to withstand these methods while maintaining a sterile barrier around packaged medical instruments or supplies.

  • What regulatory clearance does the Guardian Sterilization Wrap hold?

    The Guardian Sterilization Wrap holds FDA clearance under the Traditional 510(k) review pathway, with a clearance number of K803294. This classification confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for sterilization wraps in hospital settings.