FDA 510(k)

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves

N.º K: K220825 · 2022-07-08

SolicitanteAmerican Nitrile Operations, LLC

Fecha de decisión2022-07-08

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is the device name listed in this FDA 510(k) record. The listed applicant is American Nitrile Operations, LLC. It received FDA 510(k) clearance on 2022-07-08 under 510(k) number K220825. 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 Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves?

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is American Nitrile Operations, LLC. The 510(k) number is K220825.

When did Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves receive FDA 510(k) clearance?

Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves received FDA 510(k) clearance on 2022-07-08, under 510(k) number K220825.

Who is the listed applicant for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves?

The FDA 510(k) record lists American Nitrile Operations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves?

The FDA product code for Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves is LZA.

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Fuente oficial

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