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

Nitrile powder-free examination gloves made from synthetic nitrile latex, available in sizes XS–XXL, non-sterile and single-use. The gloves are designed for medical examination to prevent contamination between patient and examiner, and have been tested for resistance to permeation by chemotherapy drugs (including carboplatin, cisplatin, doxorubicin, and others), fentanyl citrate, simulated gastric acid, and xylazine in fentanyl citrate.

The proposed device is pink, non-powdered, fingertip textured, and ambidextrous with beaded cuff. It meets ASTM D6319-19 specifications for nitrile examination gloves with minimum tensile strength of 14 MPa, minimum elongation of 500% before aging and 400% after aging, thickness of ≥0.05 mm at palm and finger, and residual powder ≤2 mg per glove. The primary predicate (K212408) is blue-colored; the reference device (K250630) includes hyaluronic acid coating, which the proposed device lacks.

ASTM D6319-19 (nitrile glove specification), ASTM D5151-19 (hole detection), ASTM D6124-06 (residual powder), ASTM D412-16 (tensile properties), ASTM D6978-05 (chemotherapy drug permeation resistance), ISO 10993-23:2021 (skin irritation), ISO 10993-10:2021 (skin sensitization), and ISO 10993-11:2017 (acute systemic toxicity).

The device is substantially equivalent because it meets identical performance specifications and design parameters as the predicate devices in all critical functional domains: dimensional tolerances, physical properties, freedom from defects, biocompatibility, and chemotherapy drug permeation resistance. Although the color differs (pink vs. blue) and the reference device includes hyaluronic acid, these cosmetic and minor formulation variations do not affect safety or effectiveness, as the subject device passes all required non-clinical tests with equivalent or superior performance.