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Surgical Face Mask (Flat Ear Loop/CN102)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203534

by Crown Name Disposable Hygiene Products Fty. Ltd.

Identifiers

510(k) Number
K203534 FDA 510(k)
FDA Product Code
FXX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4040 FDA 510(k)
Regulation Number
878.4040 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Surgical Face Mask (Flat Ear Loop/CN102) is a disposable medical device classified as a surgical mask, designed to protect both healthcare personnel and patients from airborne microorganisms, body fluids, and particulate matter. It adheres to regulatory standards for infection control, providing a barrier against potential exposure during clinical procedures.

This single-use, non-sterile device is supplied in a disposable format and is intended for use in healthcare settings. It complies with FDA 510(k) clearance (K203534) and EU MDR authorisation, ensuring adherence to stringent regulatory requirements. The mask features a flat ear loop design for secure fitting and is manufactured by Crown Name Disposable Hygiene Products Fty. Ltd., Wuhan, China.

Frequently asked questions

What is the primary purpose of the Surgical Face Mask (Flat Ear Loop/CN102) in a clinical setting?

The Surgical Face Mask (Flat Ear Loop/CN102) is designed to protect both healthcare workers and patients from airborne microorganisms, body fluids, and particulate matter during medical procedures. Its barrier function helps reduce the risk of infection transmission in healthcare environments, adhering to infection control standards.

Is this mask reusable, or is it intended for single-use only?

This mask is explicitly labeled as a single-use device, meaning it should not be reused after one application. The disposable format ensures hygiene and reduces the risk of cross-contamination between patients or users.

How is the mask secured on the user’s face, and what makes this design practical for healthcare professionals?

The mask features a flat ear loop design, which provides a secure and comfortable fit around the ears. This design is practical for healthcare professionals as it allows for easy adjustment, reduces ear fatigue during prolonged wear, and ensures a snug seal to enhance protection against airborne particles and splashes.

What regulatory approvals does this mask hold, and how does that affect its use in different markets?

The Surgical Face Mask (Flat Ear Loop/CN102) holds FDA 510(k) clearance (K203534) and EU MDR authorization, confirming compliance with U.S. and European regulatory standards. This means it can legally be marketed and used in healthcare settings in the U.S. and EU, though buyers should verify local compliance requirements for their specific region.

Is the mask sterile, and if not, what precautions should be taken before use?

The mask is non-sterile, so it should not be used for procedures requiring sterile barriers (e.g., open wound care or sterile field applications). Before use, healthcare personnel should ensure their hands are properly cleaned or gloved, and the mask should be handled only by the intended user to avoid contamination.

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: Surgical face mask (Model: Flat Ear Loop/CN102) (K203534) — FDA 510(k ..., K203534 FDA 510(k) - Surgical face mask (Model: Flat Ear Loo..., Surgical face mask (Model: Flat Ear Loop/CN102) — FDA K203534

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Crown Name Disposable Hygiene Products Fty. Ltd.
FDA Applicant
Crown Name Disposable Hygiene Products Fty., Ltd.

Sources (2)

  • FDA 510(k) K203534 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026