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FDA 510(k)

Surgical Face Mask (Non-sterile)

N.º K: K221976 · 2022-09-20

SolicitanteXiantao Junhui Plastic Products Co., Ltd.
Fecha de decisión2022-09-20
Código de productoFXX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Face Mask (Non-sterile) is the device name listed in this FDA 510(k) record. The listed applicant is Xiantao Junhui Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K221976. 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 Surgical Face Mask (Non-sterile)?

Surgical Face Mask (Non-sterile) is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Xiantao Junhui Plastic Products Co., Ltd.. The 510(k) number is K221976.

When did Surgical Face Mask (Non-sterile) receive FDA 510(k) clearance?

Surgical Face Mask (Non-sterile) received FDA 510(k) clearance on 2022-09-20, under 510(k) number K221976.

Who is the listed applicant for Surgical Face Mask (Non-sterile)?

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

What is the FDA product code for Surgical Face Mask (Non-sterile)?

The FDA product code for Surgical Face Mask (Non-sterile) 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.

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.

Fuente oficial

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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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