Durablue Sterilization Wrap

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K123289 ↗

FDA Product Code

FRG

FDA applicant

Cardinal Health-Medical Products and Services

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ultrafree Textured Sterile Latex Powder-Free Surgical Gloves

  Class I

  FDA 510(k) K983962 Active Cleared 8 Jan 1999

• Cardinal Health Durablue Sterilization Wrap

  Class II

  FDA 510(k) K120542 Active Cleared 1 Jun 2012

• Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient Coating

  Class I

  FDA 510(k) K111868 Active Cleared 21 Sep 2011

• Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating

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  FDA 510(k) K113707 Active Cleared 27 Apr 2012

• Durablue Sterilization Wrap

  Class II

  FDA 510(k) K132060 Active Cleared 13 Dec 2013

• What is the Durablue Sterilization Wrap used for?

  The Durablue Sterilization Wrap is designed as a sterile barrier device to protect reusable medical instruments and supplies during sterilization and storage. Its primary purpose is to maintain sterility of these items in general hospital settings, ensuring they remain uncontaminated until use.

• How is the Durablue Sterilization Wrap supplied and prepared for use?

  The wrap is supplied in a non-sterile state and must undergo sterilization prior to use. It is intended for single-use applications, so each wrap is processed individually. Sterilization methods include steam or ethylene oxide, which are standard techniques for achieving sterility in medical settings.

• Is the Durablue Sterilization Wrap sterile when received?

  No, the Durablue Sterilization Wrap is not sterile when received. It must be sterilized using approved methods like steam or ethylene oxide before it can be used to protect medical instruments or supplies.

• Can the Durablue Sterilization Wrap be reused?

  No, the Durablue Sterilization Wrap is explicitly designed for single-use applications. Reusing it could compromise sterility and compromise patient safety, so it should only be used once after sterilization.

• What regulatory approval does the Durablue Sterilization Wrap hold?

  The Durablue Sterilization Wrap has received FDA 510(k) clearance under the reference number K123289. This clearance confirms it is substantially equivalent to a predicate device, meeting regulatory standards for use as a sterilization wrap in medical settings.