Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Powder-free nitrile patient examination gloves in blue color, non-sterile, designed for medical purposes to prevent contamination between patient and examiner. The gloves have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, and are available in sizes from Extra Small to XXL.

The subject device matches the predicate in material (nitrile), powder-free status, color (blue), single-use disposable design, physical dimensions (length 220-230mm depending on size, palm width 70-130mm by size), thickness (minimum 0.05mm), tensile strength (14 MPa minimum), elongation (500% before aging, 400% after aging), water-tightness (AQL 2.5), and powder content (≤2 mg per glove). Both meet ASTM D6319-19 specifications.

ASTM D6319-19 (nitrile glove specifications), ASTM D5151 (hole detection), ASTM D6124-06 (powder residue), ASTM D412-16 (tensile testing), ASTM D6978-05 (chemotherapy drug permeation), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (skin irritation and sensitization), and ISO 10993-11:2017 (acute systemic toxicity).

The subject device demonstrates substantial equivalence through identical performance across all physical and mechanical specifications, identical permeation results for all 31 tested chemotherapy drugs and additional agents (with matching breakthrough detection times, including warnings for Carmustine and Thiotepa), and identical biocompatibility test results (cytotoxicity, irritation, sensitization, and acute toxicity). The only difference—a clinical trial demonstrating reduced dermatitis potential through the modified Draize-95 test—represents an additional safety benefit supported by testing, strengthening rather than undermining equivalence.