Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid

This is a single-use, disposable nitrile powder-free examination glove intended for medical purposes to prevent contamination between patient and examiner. The gloves feature low dermatitis potential and have been tested for resistance to chemotherapy drugs (54 drugs tested), fentanyl citrate, and gastric acid. The gloves are offered in six sizes (XS through XXL) in a non-sterile state.

The subject device is made of nitrile rubber, powder-free, ambidextrous with a beaded cuff, and features a treated inner surface for smooth donning without lubricant. The predicate device (K231938) has identical material, powder-free status, single-use design, and non-sterile state. The subject device adds an additional size (XXL) and differs in color (blue-green vs. grey). Both meet ASTM D6319 for physical properties, ASTM D5151 for freedom from holes, and ASTM D6124 for residual powder.

ASTM D5151-19 (freedom from holes), ASTM D6319-19 (physical properties and dimensions), ASTM D6124-06 (residual powder), ASTM D6978-05 (chemotherapy drug permeation resistance), ISO 10993-10:2021 (skin sensitization), ISO 10993-11:2017 (systemic toxicity), and ISO 10993-23:2021 (irritation). Clinical testing used the Modified Draize-95 Test for skin sensitization.

The subject device is substantially equivalent because it has identical device classification, product codes, materials, intended use, and regulatory requirements as the predicate. Both passed equivalent biocompatibility and safety testing (skin sensitization, systemic toxicity, and irritation). The permeation testing against 54 chemotherapy drugs, fentanyl citrate, and gastric acid demonstrates comparable or superior chemical resistance; where the predicate tested 52 drugs, the subject tested all 52 plus 2 additional drugs. The only material differences (color and addition of XXL size) do not affect safety or effectiveness.