FDA 510(k)

Nitrile Exam Gloves (Chemotherapy Drug Tested)

N.º K: K223748 · 2023-01-13

SolicitanteUs Medical Glove Company, LLC

Fecha de decisión2023-01-13

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Nitrile Exam Gloves (Chemotherapy Drug Tested) is the device name listed in this FDA 510(k) record. The listed applicant is Us Medical Glove Company, LLC. It received FDA 510(k) clearance on 2023-01-13 under 510(k) number K223748. 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 Nitrile Exam Gloves (Chemotherapy Drug Tested)?

Nitrile Exam Gloves (Chemotherapy Drug Tested) is a medical device that received FDA 510(k) clearance on 2023-01-13. The listed applicant is Us Medical Glove Company, LLC. The 510(k) number is K223748.

When did Nitrile Exam Gloves (Chemotherapy Drug Tested) receive FDA 510(k) clearance?

Nitrile Exam Gloves (Chemotherapy Drug Tested) received FDA 510(k) clearance on 2023-01-13, under 510(k) number K223748.

Who is the listed applicant for Nitrile Exam Gloves (Chemotherapy Drug Tested)?

The FDA 510(k) record lists Us Medical Glove Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Exam Gloves (Chemotherapy Drug Tested)?

The FDA product code for Nitrile Exam Gloves (Chemotherapy Drug Tested) is LZA.

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Fuente oficial

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