Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate

The device is a non-sterile, powder-free, blue nitrile examination glove with an inner hyaluronic acid coating, available in sizes XS through XXL. It is designed for medical examination purposes to prevent contamination between patient and examiner, and has been tested for resistance to permeation by chemotherapy drugs, fentanyl citrate, simulated gastric acid, and xylazine.

The gloves are ambidextrous with beaded cuff, fingertip textured, made from synthetic nitrile latex, and feature an inner hyaluronic acid coating. They meet ASTM D6319-19 specifications with minimum tensile strength of 14 MPa before and after aging, minimum elongation of 500% before aging and 400% after aging, thickness of 0.05 mm minimum, and residual powder not exceeding 2 mg per glove.

ASTM D6319-19 (Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Residual Powder on Medical Gloves), ASTM D5151-19 (Detection of Holes in Medical Gloves), ASTM D6978-05 (Assessment of resistance of Medical Gloves to Permeation by Chemotherapy Drugs), ISO 10993-23 (Primary Skin Irritation), ISO 10993-10 (Dermal Sensitization), and ISO 10993-11 (Systemic Toxicity).

The proposed device is substantially equivalent because it is identical in material (nitrile), design features (ambidextrous, non-sterile, powder-free), dimensions, and biocompatibility profile to the predicate device K231365. Both devices are tested to the same permeation standards and meet identical physical property specifications. The addition of expanded chemotherapy drug testing and Xylazine/gastric acid claims does not raise new safety or effectiveness concerns, as these represent additional labeling claims supported by testing using established ASTM methods, without changing the device's fundamental design or performance characteristics.