K-number	K250944
Device name	Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
Applicant	Gmp Medicare Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Apr 23, 2025
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

This is a nitrile, powder-free, blue examination glove intended for medical purposes to prevent contamination between patient and examiner. The device has been specifically tested for compatibility with 60 chemotherapy drugs, gastric acid, xylazine, and fentanyl.

Technological characteristics

Not stated in this summary.

Test standards cited

ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs was used to test the gloves' resistance to permeation by the listed substances.

Substantial equivalence argument

Not stated in this summary. The document confirms the device is substantially equivalent to legally marketed predicate devices but does not provide the specific predicate devices or the detailed reasoning for substantial equivalence in this summary section.

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 Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl

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