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Procedure Mask, Surgical Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202899

by Kenpax International Limited

Identifiers

510(k) Number
K202899 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 Procedure Mask, Surgical Mask is a surgical face mask designed to protect healthcare personnel and patients from airborne contaminants during surgical and procedural settings. It conforms to the classification of a barrier device intended to reduce the risk of infection by filtering exhaled particles and blocking splashes or sprays.

This device is supplied as a single-use, sterile barrier mask and is regulated under FDA 510(k) clearance (K202899) and MDR compliance. It is intended for use in sterile environments such as operating rooms, minor surgical procedures, and dental treatments, adhering to standards for fluid resistance and breathability. Storage instructions and size specifications are not provided in the data.

Frequently asked questions

What types of medical procedures is this surgical mask intended to protect against airborne contaminants during?

This Procedure Mask, Surgical Mask by Kenpax International Limited is designed for use in sterile environments such as operating rooms, minor surgical procedures, and dental treatments. It helps protect both healthcare personnel and patients from airborne contaminants by filtering exhaled particles and blocking splashes or sprays, making it suitable for high-risk settings where infection control is critical.

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

The mask is explicitly labeled as a single-use device. After one use, it should be discarded to maintain sterility and prevent cross-contamination, aligning with best practices for infection control in surgical and procedural settings.

How is this mask regulated, and what does that mean for its use in clinical settings?

This mask holds FDA 510(k) clearance (K202899) and complies with MDR (Medical Device Regulation) standards. The FDA clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets safety and performance requirements for use in surgical and procedural environments. The MDR compliance further supports its suitability for European markets under strict regulatory oversight.

What kind of environments is this mask designed for, and why is that important?

The mask is specifically designed for sterile environments, including operating rooms, minor surgical procedures, and dental treatments. This classification is important because it ensures the mask meets standards for fluid resistance and breathability, reducing the risk of infection transmission during procedures where contamination control is paramount.

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
Kenpax International Limited

Sources (2)

  • FDA 510(k) K202899 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026