Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)

This is a disposable nitrile powder-free examination glove made from synthetic nitrile latex in light blue and dark blue colors. It is designed to protect examiners during patient contact and has been specifically tested for use with chemotherapy drugs, fentanyl citrate, and simulated gastric acid. The gloves come in sizes XS through XXL, are non-sterile, single-use, ambidextrous with beaded cuffs, and fingertip textured.

The device matches the predicate device in dimensions, thickness (minimum 0.05 mm for both palm and finger), physical properties (tensile strength minimum 14 MPa, elongation 500% before aging and 400% after), powder residue (≤2 mg per glove), biocompatibility properties, and permeation resistance to most chemotherapy drugs. The primary difference is color: the subject device comes in light blue and dark blue variants, while the predicate is blue only. Both meet ASTM D6319-19 specifications for nitrile examination gloves.

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

The subject device is substantially equivalent because it is identical in all critical performance characteristics to the legally marketed predicate device K240051: same material, same class, same intended use, same regulatory requirements, same sizes, and equivalent or superior permeation performance against 39 chemotherapy drugs and fentanyl/gastric acid. The color difference (light blue and dark blue versus blue) does not raise safety or effectiveness concerns because the device maintains all specified performance requirements and biocompatibility properties, with test results demonstrating performance comparable to or better than the predicate.