Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology are disposable, non-sterile medical examination gloves worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for resistance to permeation by chemotherapy drugs, fentanyl citrate, and simulated gastric acid solutions, with specific labeling warnings for drugs showing breakthrough within defined timeframes.

The subject device is a 9.5-inch, black-colored, chlorinated, nitrile, powder-free, textured glove with ambidextrous design and non-sterile status, available in sizes XS through XXL. It features textured surfaces on dorsal and palmar sides through the fingertips. Compared to the predicate K220373, both share identical dimensional, material, and design characteristics; the subject device maintains the same textured grip technology and sizing.

ASTM D6319-19 (Nitrile Examination Gloves specification), ASTM D6124-06 (Residual Powder), ASTM D5151-06 (Holes detection), ASTM D6978-05 (Chemotherapy drug permeation resistance), ISO 10993-11:2017 (Systemic toxicity), ISO 10993-10:2021 (Skin sensitization), and ISO 10993-23:2021 (Irritation).

The subject device is substantially equivalent because it is physically and functionally identical to the predicate K220373 in material composition, design, dimensions, and manufacturing (both are 9.5-inch chlorinated nitrile powder-free textured gloves). All biocompatibility and performance testing demonstrates equivalent or superior safety and effectiveness, with the subject device passing the same ASTM chemotherapy permeation testing protocol and showing no breakthrough for the same panel of drugs up to 240 minutes. The only difference—textured grip technology nomenclature—represents no meaningful change in device performance or safety.