Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid

This is a disposable, powder-free nitrile examination glove in blue color designed for medical purposes to prevent contamination between patient and examiner. The gloves have been tested for resistance to permeation by 55 chemotherapy drugs, fentanyl citrate, xylazine, gastric acid, and combinations thereof using standardized testing protocols.

The subject device matches the predicate (K244034) in all key characteristics: same product code (LZA, LZC, QDO, OPJ), same class (Class I), same size range (XS/S/M/L/XL), powder-free non-sterile construction, same physical property requirements (tensile strength ≥14 MPa, elongation ≥500% before aging), and same biocompatibility standards. The main difference is expanded testing: the subject device adds testing for gastric acid and mixed solutions (fentanyl citrate/gastric acid and xylazine/gastric acid), while maintaining identical breakthrough detection times for the 57 substances tested in both devices.

ASTM D6319-19 (nitrile glove specifications for dimensions, thickness, tensile strength, elongation, powder residual, and freedom from holes); ASTM D6978-05 (assessment of glove resistance to permeation by chemotherapy drugs); AAMI/ANSI/ISO 10993-5 (biocompatibility cytotoxicity); AAMI/ANSI/ISO 10993-10 (biocompatibility skin sensitization and irritation); 21 CFR 800.20 and ASTM D5151-19 (water leak detection).

The subject device is substantially equivalent to K244034 because both are identically constructed non-sterile, powder-free nitrile examination gloves with the same intended use, same regulatory classification, same physical and biocompatibility properties, and identical performance against 57 common hazardous substances. The subject device simply expands the tested drug/solution list to include simulated gastric acid and mixed solutions containing fentanyl citrate or xylazine with gastric acid, all achieving ≥240 minute breakthrough times. Since the base material, construction, and original drug panel are identical, and all new test substances also demonstrate adequate permeation resistance, the expanded indication for use does not create new safety or performance risks compared to the predicate.