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FDA 510(k)

Vinyl Exam Gloves, Powder Free, Clear

N.º K: K161390 · 2016-12-19

SolicitanteZibo Hongchin Plastic and Rubber Co., Ltd.
Fecha de decisión2016-12-19
Código de productoLYZ
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vinyl Exam Gloves, Powder Free, Clear is the device name listed in this FDA 510(k) record. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K161390. 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 Vinyl Exam Gloves, Powder Free, Clear?

Vinyl Exam Gloves, Powder Free, Clear is a medical device that received FDA 510(k) clearance on 2016-12-19. The listed applicant is Zibo Hongchin Plastic and Rubber Co., Ltd.. The 510(k) number is K161390.

When did Vinyl Exam Gloves, Powder Free, Clear receive FDA 510(k) clearance?

Vinyl Exam Gloves, Powder Free, Clear received FDA 510(k) clearance on 2016-12-19, under 510(k) number K161390.

Who is the listed applicant for Vinyl Exam Gloves, Powder Free, Clear?

The FDA 510(k) record lists Zibo Hongchin Plastic and Rubber Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Exam Gloves, Powder Free, Clear?

The FDA product code for Vinyl Exam Gloves, Powder Free, Clear is LYZ.

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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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