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FDA 510(k)

Dermoaroma Disposable Nitrile Examination Glove

N.º K: K212716 · 2021-12-27

SolicitanteChuzhou Harmony Gloves Medical Technology Co.,Ltd
Fecha de decisión2021-12-27
Código de productoLZA
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Dermoaroma Disposable Nitrile Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Chuzhou Harmony Gloves Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2021-12-27 under 510(k) number K212716. 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 Dermoaroma Disposable Nitrile Examination Glove?

Dermoaroma Disposable Nitrile Examination Glove is a medical device that received FDA 510(k) clearance on 2021-12-27. The listed applicant is Chuzhou Harmony Gloves Medical Technology Co.,Ltd. The 510(k) number is K212716.

When did Dermoaroma Disposable Nitrile Examination Glove receive FDA 510(k) clearance?

Dermoaroma Disposable Nitrile Examination Glove received FDA 510(k) clearance on 2021-12-27, under 510(k) number K212716.

Who is the listed applicant for Dermoaroma Disposable Nitrile Examination Glove?

The FDA 510(k) record lists Chuzhou Harmony Gloves Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dermoaroma Disposable Nitrile Examination Glove?

The FDA product code for Dermoaroma Disposable Nitrile Examination Glove 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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