Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid

The Halyard Purple Nitrile-XTRA Powder-Free Exam Gloves are disposable, 12-inch purple nitrile gloves designed for medical examination to prevent contamination between patient and examiner. They are specifically tested and labeled for use with chemotherapy drugs, fentanyl citrate, and fentanyl citrate in simulated gastric acid, providing protection against 51 chemotherapy drugs and opioids with no breakthrough detected up to 240 minutes (except Carmustine at 60 minutes).

The subject device is a 12-inch chlorinated nitrile powder-free glove with textured fingertips, available in sizes XS through XXL (adding XXL compared to the predicate). It maintains the same color (purple), sterility status (non-sterile), and basic construction as the predicate K160709, with equivalent physical properties including tensile strength and elongation meeting ASTM D6319 standards.

ASTM D6978-05 (chemotherapy drug permeation resistance), ASTM D5151-06 (pinhole detection), ASTM D6124-06 (residual powder), ASTM D6319-10 (physical dimensions and properties), ISO 10993 Parts 10, 11, and 23 (biocompatibility including irritation, acute toxicity, and skin sensitization), and the Modified Draize-95 test for low dermatitis potential.

The subject device uses the same base materials, manufacturing process, and design as the cleared predicate K160709 (12-inch chlorinated nitrile, powder-free, textured, non-sterile examination glove). The primary differences are the addition of XXL size and expanded labeling claims for chemotherapy drug and opioid protection, supported by comprehensive ASTM D6978-05 testing demonstrating equivalent or superior permeation resistance across 51 drugs plus fentanyl formulations. All non-clinical performance metrics match or exceed the predicate, and clinical data (204-subject Draize study) demonstrates the low dermatitis potential claim. The device thus maintains substantial equivalence while adding documented protective performance claims.