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Single-Use Medical Face Mask

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K210622

by Jiangxi Hongda Medical Equipment Group Co., Ltd.

Identifiers

510(k) Number
K210622 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 Single-Use Medical Face Mask is a disposable barrier device classified under the nomenclature for surgical masks, designed to protect both the wearer and surrounding patients or healthcare personnel from airborne contaminants and splashes. It provides a physical barrier against droplets, particulate matter, and microbial aerosols, ensuring minimal cross-contamination in clinical settings.

This device is intended for single-use only and is supplied in a sterile condition, adhering to regulatory standards including FDA 510(k) clearance (K210622) and MDR compliance. It is manufactured by Jiangxi Hongda Medical Equipment Group Co., Ltd., and is categorized under product code FXX. Storage requires protection from moisture and physical damage to maintain sterility and integrity.

Frequently asked questions

What is the primary purpose of this face mask in clinical settings?

This mask is designed as a disposable barrier to protect both the wearer and others from airborne contaminants, splashes, and microbial aerosols. It helps minimize cross-contamination in healthcare environments by filtering droplets and particulate matter, ensuring a safer clinical environment.

Is this mask intended for reuse, or is it meant to be used only once?

The mask is explicitly labeled for single-use only, meaning it should not be reused after one application. This ensures optimal protection and maintains sterility, as required by regulatory standards like the FDA 510(k) clearance.

How should I store this mask to keep it effective and sterile?

Storage must protect the mask from moisture and physical damage to preserve its sterility and structural integrity. Avoid exposing it to humidity or direct pressure, as this could compromise its barrier properties before use.

What regulatory pathways does this mask follow, and who manufactures it?

The mask follows FDA 510(k) clearance (K210622) and MDR compliance, confirming its adherence to U.S. and European regulatory standards. It is manufactured by Jiangxi Hongda Medical Equipment Group Co., Ltd. in Nanchang, Jiangxi Province, China.

Are there different sizes or models available for this face mask?

The provided specifications do not list specific size variations or model numbers, so this mask appears to be offered in a standard design. For exact sizing options, you would need to consult the manufacturer’s product catalog or packaging details.

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: Disposable medical surgical mask-Jiangxi Hongda | Medical protection ..., K210622 - Single-Use Medical Face Mask | FDA 510 (k), Disposable medical surgical mask-Jiangxi Hongda | Medical protection ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Jiangxi Hongda Medical Equipment Group Co., Ltd.

Sources (2)

  • FDA 510(k) K210622 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026