Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles

The Halyard Purple Nitrile Powder-Free Exam Gloves are disposable, sterile, purple-colored nitrile examination gloves intended to prevent contamination between patient and examiner. They have been tested for use with numerous chemotherapy drugs, fentanyl citrate, and simulated gastric acid, with no breakthrough detected for most substances up to 240 minutes.

The subject device is a 9.5-inch, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, sterile glove available in sizes S, M, and L. It shares the same construction characteristics (color, material, sterilization, texture) as the predicate device, with comparable physical properties including tensile strength, elongation, and thickness specifications meeting ASTM D6319 standards.

ASTM D6978-05 (chemotherapy drug permeation resistance); ASTM D6319-10 (nitrile glove specifications for physical properties and dimensions); ASTM D5151-06 (pinhole detection); ASTM D6124-06 (residual powder); ISO 10993 Parts 10, 11, and 23 (biocompatibility: irritation, acute systemic toxicity, and skin sensitization); ANSI/AAMI/ISO 11137 (sterility).

The subject device demonstrates substantial equivalence because it is identical in design, materials, construction, and intended use to the predicate device (K102032). Both are sterile, powder-free, purple nitrile gloves with identical technological characteristics and sizing. Non-clinical testing shows the subject device meets all acceptance criteria for the same standards as the predicate, including physical properties, biocompatibility, and importantly, chemotherapy drug permeation resistance for 51 drugs tested with no breakthrough at 240 minutes, supporting the same indications for use with chemotherapy drugs.