BioShield Express Sterilization Wrap

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

510(k) Number

K983719 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K022765 Active Cleared 11 Oct 2002

• Powder Free Sterile Latex Examination Gloves

  Class I

  FDA 510(k) K001141 Active Cleared 9 May 2000

• Sterile Nitrile Powder-Free Examination Gloves

  Class I

  FDA 510(k) K010211 Active Cleared 15 Feb 2001

• Ultraderm Sterile Latex Powdered Surgical Sloves with Protein Content Labeling Claim (50 Micrograms or Less)

  Class I

  FDA 510(k) K991205 Active Cleared 13 Oct 1999

• Convertors Drape Material

  Class II

  FDA 510(k) K964125 Active Cleared 23 Dec 1996

• Convertors Impervious Shoe Covers

  Class I

  FDA 510(k) K970815 Active Cleared 27 Mar 1997

See all devices from Allegiance Healthcare Corp. →

• What is the BioShield Express Sterilization Wrap used for?

  The BioShield Express Sterilization Wrap is designed as a single-use protective barrier to enclose medical devices before sterilization. Its purpose is to isolate the device during processing, preventing contamination while maintaining compatibility with standard sterilization methods. This ensures the enclosed device remains uncontaminated and can achieve sterility after processing.

• Is the wrap sterile before or after use?

  The wrap is supplied in a non-sterile state. It acts as a protective barrier during sterilization, and once the enclosed device undergoes sterilization, the wrap itself becomes sterile. This ensures the device remains uncontaminated throughout the process.

• Can the BioShield Express Sterilization Wrap be reused?

  No, the wrap is intended for single-use only. Reusing it could compromise the sterility of the enclosed device and the integrity of the barrier, posing a risk of contamination during subsequent sterilization cycles.

• What sterilization methods is this wrap compatible with?

  The wrap is designed to be compatible with standard sterilization methods, including autoclaving and other common hospital sterilization techniques. Its construction ensures structural integrity during processing, allowing it to function effectively as a protective barrier.

• How should the wrap be stored before use?

  Storage should follow manufacturer guidelines to maintain the wrap’s functionality and ensure the sterility of the enclosed device post-sterilization. Proper storage conditions help prevent damage or contamination before use, ensuring the wrap performs as intended during the sterilization process.