FDA 510(k)

Máscara Descartável de Procedimento Médico de Uso Único de Grau Médico de 3 Camadas

Número K: K220637 · 2022-03-25

Data da decisão2022-03-25

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

3 Ply Medical Grade Single Use Procedural Disposable Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Kdi Med Supply. It received FDA 510(k) clearance on 2022-03-25 under 510(k) number K220637. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3 Ply Medical Grade Single Use Procedural Disposable Face Mask?

3 Ply Medical Grade Single Use Procedural Disposable Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-25. The listed applicant is Kdi Med Supply. The 510(k) number is K220637.

When did 3 Ply Medical Grade Single Use Procedural Disposable Face Mask receive FDA 510(k) clearance?

3 Ply Medical Grade Single Use Procedural Disposable Face Mask received FDA 510(k) clearance on 2022-03-25, under 510(k) number K220637.

Who is the listed applicant for 3 Ply Medical Grade Single Use Procedural Disposable Face Mask?

The FDA 510(k) record lists Kdi Med Supply as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Ply Medical Grade Single Use Procedural Disposable Face Mask?

The FDA product code for 3 Ply Medical Grade Single Use Procedural Disposable Face Mask is FXX.

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Dispositivos Relacionados (Código: FXX)

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.

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