FDA 510(k)

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)

N.º K: K261793 · 2026-09-09

Fecha de decisión2026-09-09

Código de productoLZA

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) is the device name listed in this FDA 510(k) record. The listed applicant is Maxter Healthcare, Inc.. It received FDA 510(k) clearance on 2026-09-09 under 510(k) number K261793. 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 Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)?

Guantes de examen de nitrilo sin polvo probados para uso con medicamentos de quimioterapia y citrato de fentanilo (colores azul y negro) es un dispositivo médico que recibió la aprobación 510(k) de la FDA el 09/09/2026. El solicitante registrado es Maxter Healthcare, Inc. El número 510(k) es K261793.

When did Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) receive FDA 510(k) clearance?

Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) received FDA 510(k) clearance on 2026-09-09, under 510(k) number K261793.

Who is the listed applicant for Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)?

The FDA 510(k) record lists Maxter Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)?

The FDA product code for Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) is LZA.

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Dispositivos relacionados (Código: LZA)

Fuente oficial

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