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Surgical Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222529

by Xiantao Rayxin Medical Products Co., Ltd.

Identifiers

510(k) Number
K222529 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 Surgical Face Mask, classified under the FDA’s product code FXX. It is designed to protect healthcare personnel and patients from airborne contaminants during surgical and medical procedures, providing a barrier against droplets and particulate matter.

The mask is supplied as a single-use, non-sterile disposable item, intended for use in general and plastic surgery settings. Authorized under FDA 510(k) clearance (K222529) and MDR compliance, it is available in multiple colors (blue, green, white, red, yellow) and features ear loops for secure fitting. Storage requires dry conditions away from direct sunlight.

Frequently asked questions

What are the key differences between the colors available for this Surgical Face Mask, and does the color affect performance?

This Surgical Face Mask is available in five colors: blue, green, white, red, and yellow. The color variations are purely aesthetic and do not impact the device’s performance, filtration, or protective capabilities. All versions meet the same safety and functionality standards for blocking airborne contaminants and droplets during surgical or medical procedures.

Is this mask intended for reuse, or is it designed for single-use only? How should it be disposed of after use?

This Surgical Face Mask is explicitly designed for single-use only. After use, it should be discarded as medical waste following local regulations and facility protocols. Reuse is not recommended or supported, as it could compromise the mask’s barrier integrity and protective effectiveness.

What storage conditions are required to maintain the mask’s integrity before use?

The mask must be stored in dry conditions, away from direct sunlight and sources of moisture or extreme temperatures. Proper storage ensures the material remains intact and the ear loops retain their flexibility for a secure fit during use.

What regulatory pathways does this mask follow, and how does that affect its use in clinical settings?

This mask is authorized under FDA 510(k) clearance (K222529) and complies with MDR (Medical Device Regulation) standards. These pathways confirm its safety and performance for protecting healthcare personnel and patients from airborne contaminants in surgical and medical procedures. Clinicians can rely on its regulatory approval when selecting it for use in general and plastic surgery 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: Xiantao Rayxin Medical Products Co., Ltd.-Rayxin, Mask-产品中心-Xiantao Rayxin Medical Products Co., Ltd. -Headwear apparel, K222529 - Surgical Face Mask - General Hospital, Xiantao Rayxin Medical Products Co., Ltd. - Xiantao, Hubei, China ...

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) K222529 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026