FDA 510(k)

Non-sterile Powder Free Nitrile Examination Gloves

N.º K: K210990 · 2021-11-22

Fecha de decisión2021-11-22

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Non-sterile Powder Free Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Rubberex Alliance Sdn Bhd. It received FDA 510(k) clearance on 2021-11-22 under 510(k) number K210990. 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 Non-sterile Powder Free Nitrile Examination Gloves?

Non-sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2021-11-22. The listed applicant is Rubberex Alliance Sdn Bhd. The 510(k) number is K210990.

When did Non-sterile Powder Free Nitrile Examination Gloves receive FDA 510(k) clearance?

Non-sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2021-11-22, under 510(k) number K210990.

Who is the listed applicant for Non-sterile Powder Free Nitrile Examination Gloves?

The FDA 510(k) record lists Rubberex Alliance Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-sterile Powder Free Nitrile Examination Gloves?

The FDA product code for Non-sterile Powder Free Nitrile Examination Gloves is LZA.

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Dispositivos relacionados (Código: LZA)

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Fuente oficial

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