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FDA 510(k)

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

K-Number: K173062 · 2018-01-25

ApplicantV&Q Manufacturing Corporation
Decision Date2018-01-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is the device name listed in this FDA 510(k) record. The listed applicant is V&Q Manufacturing Corporation. It received FDA 510(k) clearance on 2018-01-25 under 510(k) number K173062. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))?

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is a medical device that received FDA 510(k) clearance on 2018-01-25. The listed applicant is V&Q Manufacturing Corporation. The 510(k) number is K173062.

When did Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) receive FDA 510(k) clearance?

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) received FDA 510(k) clearance on 2018-01-25, under 510(k) number K173062.

Who is the listed applicant for Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))?

The FDA 510(k) record lists V&Q Manufacturing Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties))?

The FDA product code for Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is FXX.

Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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