FDA 510(k)

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

K-Number: K214007 · 2022-07-27

ApplicantOwens & Minor (O&M) Halyard, Inc.

Decision Date2022-07-27

Product CodeFRG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K214007. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K214007.

When did HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap receive FDA 510(k) clearance?

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap received FDA 510(k) clearance on 2022-07-27, under 510(k) number K214007.

Who is the listed applicant for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?

The FDA 510(k) record lists Owens & Minor (O&M) Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?

The FDA product code for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is FRG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Owens & Minor (O&M) Halyard, Inc. as applicant

K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free Proce K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)K232777FLUIDSHIELD* 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)K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

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Related Devices (Code: FRG)

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLC K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.