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FDA 510(k)

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)

N.º K: K163168 · 2017-02-23

SolicitanteHebei Hongtai Plastic Products Company Limited
Fecha de decisión2017-02-23
Código de productoLYZ
Comité asesorHO
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Hongtai Plastic Products Company Limited. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K163168. 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 Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)?

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Hebei Hongtai Plastic Products Company Limited. The 510(k) number is K163168.

When did Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) receive FDA 510(k) clearance?

Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) received FDA 510(k) clearance on 2017-02-23, under 510(k) number K163168.

Who is the listed applicant for Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)?

The FDA 510(k) record lists Hebei Hongtai Plastic Products Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)?

The FDA product code for Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) 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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