FDA 510(k)

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

Número K: K261793 · 2026-09-09

Data da decisão2026-09-09

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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

Luvas de Exame de Nitrile Sem Pó Testadas para Uso com Medicamentos de Quimioterapia e Citrato de Fentanila (Cores Azul e Preto) é um dispositivo médico que recebeu aprovação da FDA 510(k) em 2026-09-09. O solicitante listado é Maxter Healthcare, Inc.. O número 510(k) é 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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