FDA 510(k)

Medical nitrile examination gloves (Model: SH001)

N.º K: K213600 · 2022-02-19

SolicitanteJiangxi Sanhao Medical Instruments Co.,Ltd

Fecha de decisión2022-02-19

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical nitrile examination gloves (Model: SH001) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Sanhao Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K213600. 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 Medical nitrile examination gloves (Model: SH001)?

Medical nitrile examination gloves (Model: SH001) is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Jiangxi Sanhao Medical Instruments Co.,Ltd. The 510(k) number is K213600.

When did Medical nitrile examination gloves (Model: SH001) receive FDA 510(k) clearance?

Medical nitrile examination gloves (Model: SH001) received FDA 510(k) clearance on 2022-02-19, under 510(k) number K213600.

Who is the listed applicant for Medical nitrile examination gloves (Model: SH001)?

The FDA 510(k) record lists Jiangxi Sanhao Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical nitrile examination gloves (Model: SH001)?

The FDA product code for Medical nitrile examination gloves (Model: SH001) is LZA.

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Fuente oficial

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