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FDA 510(k)

Disposable Vinyl/Nitrile Blend Medical Examination Gloves

N.º K: K212899 · 2021-12-11

SolicitanteBytech(Dongtai) Co., Ltd.
Fecha de decisión2021-12-11
Código de productoLYZ
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Vinyl/Nitrile Blend Medical Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Bytech(Dongtai) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-11 under 510(k) number K212899. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-12-11. The listed applicant is Bytech(Dongtai) Co., Ltd.. The 510(k) number is K212899.

When did Disposable Vinyl/Nitrile Blend Medical Examination Gloves receive FDA 510(k) clearance?

Disposable Vinyl/Nitrile Blend Medical Examination Gloves received FDA 510(k) clearance on 2021-12-11, under 510(k) number K212899.

Who is the listed applicant for Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

The FDA 510(k) record lists Bytech(Dongtai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Vinyl/Nitrile Blend Medical Examination Gloves?

The FDA product code for Disposable Vinyl/Nitrile Blend Medical Examination Gloves is LYZ.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: LYZ)

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

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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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