Program insite® Powder-Free, Disposable Nitrile Exam Gloves

Program insite® Powder-Free, Disposable Nitrile Exam Gloves are non-sterile, single-use medical examination gloves made from nitrile butadiene rubber. They are blue, ambidextrous, available in sizes S–XL with a beaded cuff, and intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The device uses nitrile butadiene rubber (NBR) material, is powder-free (meets ASTM D6124-06), features a non-chlorinated polyurethane inner coating for low-friction donning, and meets all physical and performance requirements of ASTM D6319-19. The only design difference from the predicate is color: the subject device is blue whereas the predicate is green.

ASTM D6319-19, ASTM D3767, ASTM D412, ASTM D573, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-23:2021 for physical properties, mechanical properties, watertight integrity, residual powder, and biocompatibility testing.

The Program insite device is substantially equivalent to the Showa® Medical Exam Glove (K190159) predicate because both are non-sterile, nitrile patient examination gloves with identical intended use, regulation (21 CFR 880.6250), product code (LZA), material composition, and performance characteristics. All nonclinical testing demonstrates the subject device is as safe, effective, and performs as well as or better than the predicate, with only a cosmetic color difference that does not affect safety or performance.