Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White)

Nitrile powder-free examination gloves made from synthetic nitrile latex, non-sterile and single-use, designed to prevent contamination between patient and examiner. The gloves come in black and white colors, sizes XS through XXL, and have been tested for permeation resistance to multiple chemotherapy drugs and fentanyl citrate per ASTM D6978-05.

The subject device matches the predicate in material (nitrile), powder-free design, dimensions, thickness (minimum 0.05mm), physical properties (tensile strength minimum 14 MPa, elongation 500% before aging/400% after), and biocompatibility. The primary difference is color availability: subject device offers both black and white, while predicate is black only. Chemotherapy drug permeation times differ slightly between black and white variants and compared to predicate, but all meet or exceed safety thresholds.

ASTM D6319-19 (nitrile examination gloves specification), ASTM D5151-19 (hole detection), ASTM D6124-06 (residual powder), ASTM D412-16 (tensile properties), ASTM D6978-05 (chemotherapy drug permeation), ISO 10993-23 (skin irritation), ISO 10993-10 (skin sensitization), ISO 10993-11 (acute systemic toxicity).

The subject device is substantially equivalent because it shares the same predicate device classification, regulation, product codes, material, design features, and manufacturing standards. All non-clinical performance testing demonstrates equivalent or superior results: physical properties, biocompatibility, and chemotherapy drug permeation all meet or exceed predicate specifications. The color difference (addition of white variant) does not raise safety or effectiveness concerns because the finished device passes all the same performance and biocompatibility tests. Slightly different permeation times for specific drugs are addressed through clear labeling warnings, ensuring safe use.