K-number	K250193
Device name	Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)
Applicant	Basic Medical Technology, Inc.
Product code	LZA
Device class	Class I
Decision date	Jul 9, 2025
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Nitrile powder-free disposable exam gloves intended for medical purposes to prevent contamination between patient and examiner. The gloves come in light blue and dark blue colors and are specifically tested for use with chemotherapy drugs, fentanyl citrate, and simulated gastric acid.

Technological characteristics

Not stated in this summary.

Test standards cited

ASTM D6978-05 standards for Practice for assessment of Medical Glove to Permeation by chemotherapy drugs.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence to legally marketed predicate devices predating May 28, 1976, or reclassified devices, but does not explain the specific technological or performance-based reasoning for the equivalence determination in the clearance letter itself.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)

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