Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl

This is a powder-free, non-sterile polychloroprene examination glove in green color intended for medical purposes to prevent contamination between patient and examiner. The glove has been tested for permeation resistance to 12 chemotherapy drugs (including Cisplatin, Paclitaxel, and Methotrexate) and Fentanyl citrate using ASTM D6978, with breakthrough times of >240 minutes for most drugs tested.

The proposed device is made of polychloroprene (same material as predicate), is powder-free and non-sterile, available in sizes XS through XXL, and meets ASTM D6977-19 for dimensions and physical properties. The only technological difference is color (green vs. blue in predicate), supported by biocompatibility testing showing equivalent skin irritation, sensitization, and toxicity profiles across different colors.

ASTM D6977-19 (dimensions, physical properties, powder residual), ASTM D5151-19 (freedom from holes), ASTM D412 and D573 (tensile strength and elongation before/after aging), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy drug permeation), ISO 10993-10 (skin irritation and sensitization), ISO 10993-11 (acute systemic toxicity), and 21 CFR 800.20 (pinhole defects).

The proposed device is substantially equivalent to the predicate (K212148, polychloroprene glove tested for chemotherapy drugs) because it is identical in material, construction, intended use, and regulatory classification. Both devices demonstrate equivalent performance across all critical safety and effectiveness parameters: dimensional requirements, physical properties, freedom from holes, biocompatibility, and chemotherapy drug permeation. The color difference (green vs. blue) is a minor cosmetic variation supported by identical biocompatibility results, and the addition of Fentanyl testing extends the predicate's chemotherapy claims without introducing new safety concerns, as >240 min breakthrough time exceeds clinical use duration.