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CareGUARD Sterilization Wrap

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K213907

by Care Essentials Pty Ltd

Identifiers

510(k) Number
K213907 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 CareGUARD Sterilization Wrap is a sterile barrier wrap designed to protect medical devices and instruments during sterilization processes. It is classified under the nomenclature category for sterilization wraps, ensuring contamination control and maintaining sterility of packaged items.

This wrap is intended for use in general hospital settings, supplied as a single-use item to prevent cross-contamination during sterilization cycles. It is authorized under FDA 510K clearance (K213907) and meets MDR requirements, ensuring compliance with regulatory standards. Available in standard sizes, it is packaged for sterile use and must be stored in a clean, dry environment.

Frequently asked questions

What is the CareGUARD Sterilization Wrap primarily used for in a hospital setting?

The CareGUARD Sterilization Wrap is designed as a sterile barrier wrap to protect medical devices and instruments during sterilization processes. Its purpose is to prevent contamination and maintain sterility of packaged items throughout the sterilization cycle, ensuring safe handling in general hospital environments.

Is the CareGUARD Sterilization Wrap intended for reuse, or is it meant to be used only once?

The CareGUARD Sterilization Wrap is explicitly supplied as a single-use item. This design choice prevents cross-contamination between sterilization cycles, aligning with best practices for infection control in medical settings.

How should the CareGUARD Sterilization Wrap be stored before use?

The wrap must be stored in a clean, dry environment to preserve its sterility. Since it is packaged for sterile use, exposure to moisture or contaminants could compromise its protective properties before application.

What regulatory pathways does the CareGUARD Sterilization Wrap follow for market authorization?

The device is authorized through FDA 510(k) clearance (K213907) under the Traditional pathway, with a decision classification of *Substantially Equivalent* to a predicate device. It also complies with MDR (Medical Device Regulation) requirements, ensuring adherence to both U.S. and EU regulatory standards.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Care Essentials Pty Ltd
FDA Applicant
Care Essentials Pty, Ltd.

Sources (2)

  • FDA 510(k) K213907 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026