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Dukal Crepe Paper Sterilization Wrap

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252823

by Dukal LLC

Identifiers

510(k) Number
K252823 FDA 510(k)
FDA Product Code
FRG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6850 FDA 510(k)
Regulation Number
880.6850 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Dukal Crepe Paper Sterilization Wrap is a medical-grade wrap classified as a sterilization wrap (FDA Product Code: FRG). Designed for use in healthcare settings, it provides a protective barrier to maintain sterility during autoclave or other sterilization processes, ensuring contamination-free packaging of medical devices or instruments. Constructed from crepe paper, it is intended for single-use applications where integrity and barrier performance are critical. This wrap helps preserve the sterility of enclosed items throughout storage and transport, reducing the risk of microbial contamination.

This wrap is supplied as a single-use item and is intended for use in hospital or clinical environments where sterilization procedures are performed. It is not intended for reuse and must be discarded after one use to comply with infection control protocols. The device has received FDA 510(k) clearance (K252823) under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a legally marketed predicate device. No specific MRI safety or sterility assurance level (e.g., Class I, II, or III) is stated in the provided data, but it adheres to standard sterilization wrap performance standards for healthcare use.

Frequently asked questions

What is the Dukal Crepe Paper Sterilization Wrap used for in a clinical setting?

The Dukal Crepe Paper Sterilization Wrap is designed as a protective barrier to maintain sterility during autoclave or other sterilization processes. It ensures that medical devices or instruments remain contamination-free while being packaged, stored, or transported in healthcare environments. Its primary purpose is to preserve sterility integrity for single-use applications, reducing the risk of microbial contamination.

Is the Dukal Crepe Paper Sterilization Wrap intended for reuse, or is it meant to be discarded after one use?

The Dukal Crepe Paper Sterilization Wrap is explicitly intended for single-use only. It must be discarded after one use to comply with infection control protocols, as reuse could compromise sterility and barrier performance. This aligns with standard practices for sterilization wraps in healthcare settings.

How is the Dukal Crepe Paper Sterilization Wrap supplied, and what type of environment is it intended for?

The wrap is supplied as a single-use item and is intended exclusively for use in hospital or clinical environments where sterilization procedures (such as autoclaving) are performed. It is not designed for home use or non-medical settings. The packaging and construction ensure it meets medical-grade standards for barrier protection during sterilization.

What regulatory pathway was followed for the FDA clearance of the Dukal Crepe Paper Sterilization Wrap?

The Dukal Crepe Paper Sterilization Wrap received FDA 510(k) clearance (K252823) under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a legally marketed predicate device. This clearance confirms it meets regulatory standards for sterilization wraps classified under FDA Product Code FRG (sterilization wrap) and is suitable for use in healthcare settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dukal Crepe Paper Sterilization Wrap (K252823) — FDA 510 (k ..., PDF 2 Fleetwood Court Re: K252823 Trade/Device Name: Dukal Crepe Paper ..., K252823 FDA 510 (k) - Dukal Crepe Paper Sterilization Wrap, Dukal Crepe Paper Sterilization Wrap - FDA 510(k) K252823

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dukal LLC
FDA Applicant
Dukal, LLC

Sources (1)

  • FDA 510(k) K252823 24 fields · synced Sep 20, 2026