K-number	K252549
Device name	Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
Applicant	Kossan International Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Jan 13, 2026
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is a non-sterile, powder-free nitrile examination glove in two dual-color variants (white-green and white-blue) intended for medical purposes to prevent contamination between patient and examiner. The gloves were specifically tested for resistance to permeation by chemotherapy drugs, fentanyl citrate, xylazine HCl, and simulated gastric acid.

Technological characteristics

Not stated in this summary.

Test standards cited

ASTM D6978-05 (Reapproved 2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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