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FDA 510(k)

Disposable Nitrile Gloves

N.º K: K212009 · 2021-09-15

SolicitanteJiangsu Shenglijie Safety Products Co., Ltd.
Fecha de decisión2021-09-15
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Nitrile Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Shenglijie Safety Products Co., Ltd.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K212009. 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 Disposable Nitrile Gloves?

Disposable Nitrile Gloves is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Jiangsu Shenglijie Safety Products Co., Ltd.. The 510(k) number is K212009.

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

Disposable Nitrile Gloves received FDA 510(k) clearance on 2021-09-15, under 510(k) number K212009.

Who is the listed applicant for Disposable Nitrile Gloves?

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

What is the FDA product code for Disposable Nitrile Gloves?

The FDA product code for Disposable 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

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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