Halyard ONE-STEP Sterilization Wrap

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

510(k) Number

K192147 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

  Class II

  FDA 510(k) K181959 Active Cleared 22 Mar 2019

• HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)

  Class II

  FDA 510(k) K232820 Active Cleared 4 Jun 2024

• Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

  Class I

  FDA 510(k) K182096 Active Cleared 2 Nov 2018

• HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

  Class II

  FDA 510(k) K214007 Active Cleared 27 Jul 2022

• FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)

  Class II

  FDA 510(k) K232777 Active Cleared 1 Jul 2024

• HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

  Class II

  FDA 510(k) K232806 Active Cleared 7 Jun 2024

See all devices from Owens & Minor (O&M) Halyard, Inc. →

• What is the Halyard ONE-STEP Sterilization Wrap used for?

  The Halyard ONE-STEP Sterilization Wrap is designed to maintain sterility and protect medical instruments during storage and transport. It ensures that devices remain uncontaminated between sterilization and use, reducing the risk of infection in clinical environments.

• Is the Halyard ONE-STEP Sterilization Wrap intended for single-use or reuse?

  This wrap is explicitly intended for single-use only. After opening or exposure to non-sterile conditions, it should be discarded to prevent contamination of medical instruments, ensuring patient safety and compliance with sterile processing protocols.

• What storage conditions are recommended for the Halyard ONE-STEP Sterilization Wrap?

  The wrap should be stored in a dry, cool environment to preserve its sterility and integrity. Avoid exposure to moisture, direct sunlight, or extreme temperatures, as these factors can compromise the material and potentially affect its protective properties.

• Are there different sizes available for the Halyard ONE-STEP Sterilization Wrap?

  Yes, the Halyard ONE-STEP Sterilization Wrap is available in various sizes to accommodate different medical instruments and packaging needs. The specific sizes can be referenced in the product documentation or by contacting the manufacturer for detailed sizing options.

• Is the Halyard ONE-STEP Sterilization Wrap MRI-safe?

  Yes, the Halyard ONE-STEP Sterilization Wrap is MRI-safe, meaning it can be used in magnetic resonance imaging environments without interfering with the imaging process or posing a risk to patients or equipment.