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Disposable Surgical Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K153496

by Xiantao Rayxin Medical Products Co., Ltd.

Identifiers

510(k) Number
K153496 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)

This device is a Disposable Surgical Face Mask, classified under the nomenclature for protective respiratory devices. It is designed to provide a barrier against airborne contaminants, splashes, and droplets during surgical and medical procedures, ensuring protection for both patients and healthcare providers.

The mask is intended for single-use and supplied in sterile packaging. It is regulated under FDA 510K clearance (K153496) and EU MDR compliance, adhering to standards for disposable medical devices. Available in standard sizes, it must be stored in a clean, dry environment to maintain sterility and integrity before use.

Frequently asked questions

What is the primary purpose of this disposable surgical face mask and who should use it?

This disposable surgical face mask is designed to create a barrier against airborne contaminants, splashes, and droplets, ensuring protection during surgical and medical procedures. It is intended for use by healthcare providers and patients to minimize exposure to potential infections in clinical settings.

Is this mask meant for reuse, or is it single-use only?

The mask is explicitly labeled for single-use only, meaning it should not be reused after one procedure. This ensures optimal protection and sterility, as it is supplied in sterile packaging.

How should I store this mask before use to maintain its sterility?

The mask must be stored in a clean, dry environment to preserve its sterility and structural integrity. Avoid exposure to moisture, extreme temperatures, or contamination, as this could compromise its effectiveness.

What regulatory pathways has this device undergone, and what does that mean for its use?

This mask has undergone FDA 510(k) clearance (K153496) and complies with EU MDR (Medical Device Regulation) standards. The FDA clearance indicates it is deemed substantially equivalent to a legally marketed device, while MDR compliance ensures it meets EU safety, performance, and traceability requirements for medical devices.

Are there different sizes available for this mask, or is it only offered in a standard fit?

The device description specifies it is available in standard sizes, but no specific variations (e.g., adult, pediatric, or custom fits) are mentioned. If sizing is a concern, verify compatibility with the patient or user’s needs before use.

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
Xiantao Rayxin Medical Products Co., Ltd.

Sources (2)

  • FDA 510(k) K153496 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 10, 2026