BioShield Heavy Duty and Super Duty Express Sterilization Wrap

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

510(k) Number

K993871 ↗

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 Heavy Duty and Super Duty Express Sterilization Wrap used for in a clinical setting?

  This wrap is designed to create a protective barrier around medical instruments or devices during sterilization, preventing contamination during the process. It ensures that the enclosed items remain sterile until they are ready for use in clinical settings, such as hospitals or surgical environments.

• Is the BIOSHIELD Heavy Duty and Super Duty Express Sterilization Wrap intended for reuse, or is it meant to be used only once?

  The wrap is explicitly labeled as a single-use item, meaning it should not be reused after one sterilization cycle. This ensures optimal contamination prevention and sterility integrity, as reuse could compromise its protective properties.

• How should I store the BIOSHIELD Heavy Duty and Super Duty Express Sterilization Wrap before use?

  Since the wrap is supplied as non-sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for shelf-life and handling to maintain its integrity before sterilization processing.

• Are there different sizes or models available for the BIOSHIELD Heavy Duty and Super Duty Express Sterilization Wrap?

  The provided data does not specify distinct sizes or models beyond the Heavy Duty and Super Duty designations, which likely refer to varying thickness or strength for different sterilization needs. For exact sizing options, consult Allegiance Healthcare’s product documentation or technical support.

• Can this wrap be used with any standard sterilization method, or are there specific limitations?

  The wrap is compatible with standard sterilization methods, meaning it can be used with autoclaves, ethylene oxide, or other approved techniques. However, always verify compatibility with your facility’s specific sterilization equipment and protocols to ensure proper sealing and sterility assurance.