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FDA 510(k)

Disposable Medical Face Mask

N.º K: K213806 · 2022-03-12

SolicitanteXiantao Zhibo Nonwoven Products Co., Ltd.
Fecha de decisión2022-03-12
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Zhibo Nonwoven Products Co., Ltd.. It received FDA 510(k) clearance on 2022-03-12 under 510(k) number K213806. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Medical Face Mask?

Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-12. The listed applicant is Xiantao Zhibo Nonwoven Products Co., Ltd.. The 510(k) number is K213806.

When did Disposable Medical Face Mask receive FDA 510(k) clearance?

Disposable Medical Face Mask received FDA 510(k) clearance on 2022-03-12, under 510(k) number K213806.

Who is the listed applicant for Disposable Medical Face Mask?

The FDA 510(k) record lists Xiantao Zhibo Nonwoven Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Medical Face Mask?

The FDA product code for Disposable Medical Face Mask is FXX.

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Dispositivos relacionados (Código: FXX)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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