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Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K173062

by V&Q Manufacturing Corporation

Identifiers

510(k) Number
K173062 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 Non-Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is a surgical mask designed to protect against the transfer of microorganisms, blood, body fluids, and particulate materials. Classified under product code FXX, it falls under the category of surgical masks and is intended for single-use applications in healthcare settings.

Supplied as a single-use disposable device, these masks are intended for use by operating room personnel and general healthcare workers. They are regulated under FDA 510(k) clearance (K173062) and the EU Medical Device Regulation (MDR), with no indication of MRI compatibility. Storage and handling should adhere to standard single-use medical device protocols to ensure sterility and efficacy.

Frequently asked questions

What are the key differences between the VQN0185W and VQN0185B models of this face mask?

The VQN0185W model features ear loops for easy attachment, while the VQN0185B model includes ties that must be secured around the head. Both models are designed as single-use surgical masks to protect against microorganisms, blood, body fluids, and particulate materials in healthcare settings.

Are these masks intended for reuse, or are they meant to be discarded after a single use?

These masks are explicitly designed for single-use only in healthcare environments, including operating rooms and general clinical settings. Reuse is not recommended, as it could compromise sterility and protective performance.

How should these masks be stored to maintain their effectiveness?

Since these are single-use disposable devices, they should be stored in a clean, dry environment following standard medical device protocols. Avoid exposure to moisture, extreme temperatures, or contamination to preserve sterility and structural integrity before use.

What regulatory pathways have been followed for these face masks?

The VQN0185W and VQN0185B models have undergone FDA 510(k) clearance (K173062) under the traditional review process, with a decision of *Substantially Equivalent* to a predicate device. They also comply with the EU Medical Device Regulation (MDR). Neither model is indicated for MRI compatibility.

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: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), K173062 FDA 510 (k) - Non Woven Face Mask (Models: VQN0185W (..., Non Woven Face Mask (Models: VQN0185W (earloop) And… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
V&Q Manufacturing Corporation

Sources (2)

  • FDA 510(k) K173062 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026