Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

This is a disposable, non-sterile, powder-free nitrile examination glove colored blue, designed to be worn on an examiner's hand to prevent contamination between patient and examiner. The glove has been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate, with breakthrough times documented for 37 chemotherapy drugs and fentanyl citrate injection.

The subject device is physically identical to the predicate device (K222225) in materials (nitrile), color (blue), design (single-use, non-sterile, powder-free, ambidextrous), and performance specifications (dimensions, thickness, tensile strength, powder residue). The sole difference is that the subject device has been additionally tested for fentanyl citrate permeation, whereas the predicate was tested only for chemotherapy drugs.

ASTM D6319-19 for glove specifications; ASTM D6978-05 (Reapproved 2019) for chemotherapy drug and fentanyl citrate permeation resistance; ASTM D5151-19 for hole detection; ASTM D6124-06(R17) for residual powder; ISO 10993-10 for skin irritation and sensitization; ISO 10993-11 for acute systemic toxicity.

The subject device is substantially equivalent because it is physically and chemically identical to the predicate device with the same materials, manufacturing process, and intended use as a barrier to contamination. The only modification is the addition of fentanyl citrate permeation testing data showing breakthrough time greater than 240 minutes; this expanded testing claim does not change the device's safety or effectiveness profile, only broadens its documented protective applications. All chemotherapy drug test results are identical to the predicate, and biocompatibility and physical property testing remain unchanged.