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FDA 510(k)

Disposible Nitrile Gloves

N.º K: K223280 · 2023-05-08

SolicitanteHolik Asia Group Co.,Ltd
Fecha de decisión2023-05-08
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposible Nitrile Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Holik Asia Group Co.,Ltd. It received FDA 510(k) clearance on 2023-05-08 under 510(k) number K223280. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposible Nitrile Gloves?

Disposible Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2023-05-08. The listed applicant is Holik Asia Group Co.,Ltd. The 510(k) number is K223280.

When did Disposible Nitrile Gloves receive FDA 510(k) clearance?

Disposible Nitrile Gloves received FDA 510(k) clearance on 2023-05-08, under 510(k) number K223280.

Who is the listed applicant for Disposible Nitrile Gloves?

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

What is the FDA product code for Disposible Nitrile Gloves?

The FDA product code for Disposible Nitrile Gloves is LZA.

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Dispositivos relacionados (Código: LZA)

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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