Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue

This is a disposable nitrile powder-free patient examination glove made of nitrile butadiene rubber, available in small to extra-large sizes with beaded cuffs and fingertip texture. The glove is designed for general medical examination use to prevent contamination between patient and examiner, and has been tested for resistance to permeation by 13 chemotherapy drugs and fentanyl citrate according to ASTM D6978-05(2023).

The device is identical to the predicate (K240080) in material (nitrile butadiene rubber), design (single-use, non-sterile, powder-free, ambidextrous, beaded cuff), and regulatory classification (Class I, 21 CFR 880.6250). Primary differences are: color (blue vs. green), coating ingredient (Tremella Fuciformis extract vs. aloe vera), available sizes (S, M, L, XL vs. XS through XXL in predicate), and the subject device tested oxaliplatin which the predicate did not.

ASTM D6319-19 (physical dimensions and properties), ASTM D5151-19 (watertightness/hole detection), ASTM D6124-06 (powder content), ASTM D412 (tensile strength and elongation), ASTM D6978-05(2023) (chemotherapy drug permeation), ISO 10993 series (cytotoxicity, irritation, sensitization, acute systemic toxicity), ISO 11737-1:2018 (bioburden), and USP <151> (pyrogenicity).

The subject device demonstrates substantial equivalence because it uses the same nitrile rubber material, shares identical glove design and construction (beaded cuff, fingertip texture, single-use, non-sterile, powder-free), and is classified identically under the same regulation. Although the coating differs (Tremella Fuciformis vs. aloe), both are non-animal derived and biocompatibility testing is identical for both formulations with the subject device passing all required standards. The subject device's chemotherapy drug permeation results meet or exceed the predicate's—showing breakthrough times ≥240 minutes for 11 of 13 tested drugs with only two drugs (Carmustine and Thiotepa) showing low permeation times similar to the predicate, supported by additional safety testing (bioburden and pyrogenicity) performed due to the fungal-derived coating material.