FDA 510(k) clearance · back to tracker

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

Maxter Healthcare, Inc. cleared K261793 on 2026-09-09, decision: substantially equivalent

K-number

K261793

Sponsor

Maxter Healthcare, Inc.

Device

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

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-09-09

Product code

LZA

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.6250

Official FDA record

Open K261793on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.