Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid

These are sterile, powder-free surgical gloves made of synthetic polyisoprene rubber with a synthetic coating for easy donning. They are single-use, disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination. The gloves have been specifically tested for resistance to permeation by 35 chemotherapy drugs and simulated gastric acid.

The subject device is identical to the predicate (Sempermed Syntegra IR) in material, coating, design features (single-use, powder-free, anatomical shape, beaded cuff), dimensions, physical properties, sterility assurance level, and biocompatibility outcomes. The main differences are trade name, product owner, color (green vs. natural), sterilization method (radiation vs. not specified), and added chemotherapy/gastric acid permeation testing—none of which affect core device performance or safety.

ASTM D3577-19 (surgical glove specifications), ASTM D5151-19 (freedom from holes), ASTM D6124 (powder residue), ASTM D6978-05 (chemotherapy drug permeation), ISO 11137-1:2006 (radiation sterilization and sterility assurance), ISO 10993-10:2010 (skin irritation and sensitization), ISO 10993-11:2017 (acute systemic toxicity and pyrogenicity), and USP <85> (bacterial endotoxins).

The device meets all applicable consensus standards for surgeon's gloves (dimensions, physical properties, freedom from holes, powder residue) and passes all biocompatibility tests identically to the predicate. The added chemotherapy and gastric acid permeation testing (per ASTM D6978-05) demonstrates performance beyond the predicate's claims, with 35 drugs showing breakthrough times of ≥240 minutes (except two with notably low times that are contraindicated in labeling). Since the device's core construction and performance in standard surgeon's glove tests are equivalent to the predicate, and additional chemical resistance testing poses no safety concern, the device is substantially equivalent for its intended use of wound protection in surgical settings.