Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Powder-free nitrile examination gloves in blue and black colors, designed for medical purposes to prevent contamination between patient and examiner. The gloves are single-use, disposable, non-sterile, and have been tested for chemical permeation resistance to multiple chemotherapy drugs (including cisplatin, cyclophosphamide, doxorubicin, fluorouracil, methotrexate, paclitaxel, etoposide, and dacarbazine) and fentanyl citrate, with a warning against use with carmustine and thiotepa due to very low breakthrough times.

Both subject and predicate devices are powder-free, nitrile, ambidextrous examination gloves with beaded cuffs and Class I classification. Subject device adds XXL size (predicate offers XS-XL) and includes blue/black colors (predicate was purple). Physical specifications are identical: finger and palm thickness of 0.05mm minimum, tensile strength of 14 MPa before and after aging, elongation of 500% before and 400% after aging, and freedom from holes at G-I AQL 2.5. Subject device supports 3-year shelf life while predicate shelf life was not stated.

ASTM D6319-19 (nitrile glove specifications), ASTM D5151-19 (glove hole detection), ASTM D6124-06 (powder residue), ASTM D412-16 (tensile properties), ASTM D6978-05 (chemotherapy drug permeation), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-11 (acute systemic toxicity), and ISO 10993-23 (skin irritation).

The subject device meets identical physical and performance specifications to the predicate across all measured parameters (dimensions, tensile strength, elongation, hole resistance, powder residue). Biocompatibility testing produces equivalent results. Chemical permeation performance against tested chemotherapy drugs and fentanyl citrate is substantially similar, with minor variations in breakthrough times for carmustine and thiotepa that are clinically managed by clear labeling warnings against use with those drugs. The addition of XXL size and different colors do not alter the fundamental function or safety profile, as evidenced by passing all performance and biocompatibility requirements.