Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs

Powder Free Nitrile Examination Gloves in violet, black, and green colors designed for medical examination use to prevent contamination between patient and examiner. The gloves have been tested for resistance to permeation by chemotherapy drugs (including Bleomycin, Cisplatin, Doxorubicin, and 31 others), Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019) standard.

Nitrile material, ambidextrous, single-use, non-sterile, powder-free design in sizes XS through XXL with identical dimensional specifications (length, palm width, thickness) and mechanical properties (tensile strength ≥14 MPa, elongation 500% before aging, 400% after) as the predicate device. Key difference is color (violet, black, green vs. blue predicate) and inclusion of additional product codes (OPJ added to predicate's LZA, LZC, QDO).

ASTM D6319-19 (nitrile glove specifications), ASTM D412-16(2021) (tensile testing), ASTM D5151-19 (hole detection), ASTM D6124-06(2022) (powder residue), ASTM D6978-05(2019) (chemotherapy drug permeation), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-11:2017 (acute systemic toxicity), ISO 10993-23:2021 (skin irritation).

The subject device uses identical nitrile material, design, construction, and mechanical properties as the predicate device K221269. All non-clinical performance tests (physical dimensions, tensile strength, elongation, water leak, powder residue, biocompatibility) yielded same or better results than the predicate. Chemical permeation results for 33 chemotherapy drugs and 4 other drugs met or exceeded predicate performance (minimum breakthrough times ≥240 minutes for most compounds except Carmustine and Thiotepa, which carry explicit warnings). Color variation and additional product code do not raise safety or effectiveness concerns as evidenced by identical physical and biocompatibility test results.