FDA 510(k)

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

Numéro K : K261793 · 2026-09-09

Date de décision2026-09-09

Code produitLZA

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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

Gants d'examen en nitrile sans poudre testés pour l'utilisation avec des médicaments de chimiothérapie et le citrate de fentanyl (couleurs bleue et noire) est un dispositif médical qui a reçu une autorisation 510(k) de la FDA le 2026-09-09. Le demandeur inscrit est Maxter Healthcare, Inc.. Le numéro 510(k) est 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.

Essais cliniques associés

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Dispositifs connexes (Code : LZA)

Source officielle

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