Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

These are non-sterile, powder-free nitrile examination gloves available in blue and black colors, designed to prevent contamination between patient and examiner. They have been specifically tested for resistance to permeation by 14 chemotherapy drugs and fentanyl citrate, with a warning against use with Carmustine and Thiotepa due to extremely low breakthrough times.

The subject device is identical in design and formulation to the predicate device K230121. Both are ambidextrous, polymer-coated or chlorinated, powder-free nitrile gloves in sizes XS through XL. The key difference is that the subject device added testing for two additional chemotherapy drugs (Methotrexate and Mitomycin C), expanding the claim from 12 to 14 chemotherapy drugs plus fentanyl citrate.

ASTM D6319-19 for glove dimensions and physical properties; ASTM D5151-19 for water leak testing; ASTM D6124-06 for powder residue; ASTM D6978-05 for resistance to permeation by chemotherapy drugs; ISO 10993-10 for skin irritation and sensitization; ISO 10993-5:2009 for in vitro cytotoxicity; ISO 10993-11 for acute systemic toxicity.

The subject device demonstrates substantial equivalence because it is identical in design, construction, materials, size specifications, and physical properties to the predicate K230121. All non-clinical testing results are identical or superior to the predicate, including tensile strength, elongation, water leak resistance, and biocompatibility. The additional testing for two chemotherapy drugs (Methotrexate and Mitomycin C) shows comparable or better permeation resistance (>240 minutes) compared to the predicate's tested agents, expanding rather than diminishing the device's demonstrated safety profile.