Genesis Container System

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

Full name

Allegiance Genesis Container System

510(k) Number

K983299 ↗

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 Allegiance Genesis Container System used for?

  The Allegiance Genesis Container System is designed to protect and contain surgical instruments and devices during sterilization and storage. Its hard coat anodized aluminum construction helps maintain sterility and prevents contamination, ensuring instruments remain safe for use in healthcare environments.

• Is the Genesis Container System reusable or single-use?

  The Genesis Container System is supplied as a reusable device. This design allows healthcare facilities to use it repeatedly after proper cleaning and sterilization, reducing waste and improving cost efficiency.

• What material is the container made from?

  The container is constructed from hard coat anodized aluminum, a durable material chosen for its ability to withstand repeated sterilization cycles while maintaining structural integrity and sterility.

• Does this container require special storage conditions?

  While the Genesis Container System is designed for general hospital use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its protective properties and prevent corrosion.

• What regulatory clearance does this device hold?

  The Allegiance Genesis Container System holds FDA 510(k) clearance under the reference number K983299, classified under product code FRG for sterilization containers. This clearance was granted through a traditional review process by the FDA’s General Hospital Advisory Committee.