Cardinal Health Durablue Sterilization Wrap

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

510(k) Number

K120542 ↗

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

• 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

  Class I

  FDA 510(k) K113707 Active Cleared 27 Apr 2012

• Durablue Sterilization Wrap

  Class II

  FDA 510(k) K123289 Active Cleared 28 Feb 2013

• Durablue Sterilization Wrap

  Class II

  FDA 510(k) K132060 Active Cleared 13 Dec 2013

• What is the Cardinal Health Durablue Sterilization Wrap used for?

  It is used to maintain the sterility of medical devices and instruments during storage and transport in general hospital settings by providing a barrier against contamination, supporting hygiene standards and the effectiveness of sterilization processes.

• What sizes and model numbers are available for the Durablue Sterilization Wrap?

  The wrap is supplied in 36x36 inch and 54x54 inch sizes, corresponding to model numbers CH100036 and CH500054, as indicated in the device specifications.

• Is the Cardinal Health Durablue Sterilization Wrap sterile and intended for single use?

  The device is a sterilization wrap designed to maintain sterility during storage and transport, but the provided data does not specify whether it is sold sterile or intended for single-use versus reuse; therefore, its sterility status and reusability cannot be confirmed from the given information.

• How should the Durablue Sterilization Wrap be stored?

  The device data does not include specific storage instructions for the Durablue Sterilization Wrap, so storage conditions such as temperature, humidity, or light exposure requirements are not specified in the provided information.

• What regulatory pathway was used for the Cardinal Health Durablue Sterilization Wrap?

  The device received FDA 510(k) clearance under submission K120542, determined to be substantially equivalent to a legally marketed device, as indicated by the decision code SESE and clearance type Traditional.