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FDA 510(k)

Dukal Crepe Paper Sterilization Wrap

K-Number: K252823 · 2026-05-28

ApplicantDukal, LLC
Decision Date2026-05-28
Product CodeFRG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Dukal Crepe Paper Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Dukal, LLC. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K252823. 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 Dukal Crepe Paper Sterilization Wrap?

Dukal Crepe Paper Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Dukal, LLC. The 510(k) number is K252823.

When did Dukal Crepe Paper Sterilization Wrap receive FDA 510(k) clearance?

Dukal Crepe Paper Sterilization Wrap received FDA 510(k) clearance on 2026-05-28, under 510(k) number K252823.

Who is the listed applicant for Dukal Crepe Paper Sterilization Wrap?

The FDA 510(k) record lists Dukal, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dukal Crepe Paper Sterilization Wrap?

The FDA product code for Dukal Crepe Paper Sterilization Wrap is FRG.

Other records listing Dukal, LLC as applicant

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.

K233262Dukal SMS Sterilization WrapK212464Dukal Corporation AAMI Level 4 Open-Back Protective GownK210321Dukal Corporation Level 1 Pediatric Face MaskK203237Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical GownK201732Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie OnK201421Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons

View all 7 devices →

Related Devices (Code: FRG)

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.

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.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.K243179Sterilization Pouch and RollYichang Xinxin Paper Products Co., Ltd.

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.

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