Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine

This is a disposable, powder-free nitrile examination glove in blue color intended for medical use to prevent contamination between patient and examiner. The gloves have been specifically tested for resistance to permeation by 57 chemotherapy drugs, fentanyl citrate, and xylazine, meeting resistance standards for these hazardous substances.

The subject device is identical to the predicate in material composition, dimensions, physical properties (tensile strength, elongation), powder residue limits, and biocompatibility requirements. The key difference is the addition of testing for xylazine permeation resistance (no breakthrough at 240 minutes) compared to the predicate which only tested chemotherapy drugs and fentanyl citrate. Both comply with ASTM D6319-19 for nitrile gloves and ASTM D6978-05 for chemotherapy drug permeation resistance.

ASTM D6319-19 (nitrile examination glove specifications), ASTM D6978-05 (resistance to permeation by chemotherapy drugs), ASTM D5151-19 (freedom from holes/water leak test), AAMI/ANSI/ISO 10993-5 (biocompatibility cytotoxicity), AAMI/ANSI/ISO 10993-10 (skin sensitization and irritation), and 21 CFR 800.20.

The subject device is substantially equivalent because it uses identical materials, manufacturing processes, and dimensions as the predicate device, meets all the same performance standards for tensile strength, elongation, and biocompatibility, and demonstrates equivalent or superior resistance to permeation by chemotherapy drugs and fentanyl citrate. The addition of xylazine testing represents an expansion of the intended use indication rather than a change to the device itself—the glove composition and performance characteristics remain unchanged, and xylazine resistance testing shows the same or better performance (>240 minutes breakthrough time) as achieved with other tested substances.