FDA 510(k)

Powder Free Nitrile Examination Gloves (White, Blue and Black)

N.º K: K212998 · 2022-02-19

Fecha de decisión2022-02-19

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder Free Nitrile Examination Gloves (White, Blue and Black) is the device name listed in this FDA 510(k) record. The listed applicant is Alcatron Gloves Factory. It received FDA 510(k) clearance on 2022-02-19 under 510(k) number K212998. 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 Powder Free Nitrile Examination Gloves (White, Blue and Black)?

Powder Free Nitrile Examination Gloves (White, Blue and Black) is a medical device that received FDA 510(k) clearance on 2022-02-19. The listed applicant is Alcatron Gloves Factory. The 510(k) number is K212998.

When did Powder Free Nitrile Examination Gloves (White, Blue and Black) receive FDA 510(k) clearance?

Powder Free Nitrile Examination Gloves (White, Blue and Black) received FDA 510(k) clearance on 2022-02-19, under 510(k) number K212998.

Who is the listed applicant for Powder Free Nitrile Examination Gloves (White, Blue and Black)?

The FDA 510(k) record lists Alcatron Gloves Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder Free Nitrile Examination Gloves (White, Blue and Black)?

The FDA product code for Powder Free Nitrile Examination Gloves (White, Blue and Black) is LZA.

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Dispositivos relacionados (Código: LZA)

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Fuente oficial

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