Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

Powder Free Natural Rubber Latex Examination Gloves in blue, non-sterile condition with a protein content claim of 50 micrograms per dm² or less. These are single-use disposable gloves intended for medical examination purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient.

The subject device is made of natural rubber latex, powder-free, finger-textured, available in five sizes (Small through Extra Extra Large), and non-sterile. It matches the predicate in material, color, surface treatment, size range, and sterility status. Key difference: the subject device has a lower protein acceptance criterion (<50 µg/dm²) compared to the predicate (≤200 µg/dm²) to support a low-protein claim. Dimensions, thickness, tensile strength, elongation, and watertight performance are comparable.

ASTM D3578-19 (rubber examination gloves specification), ASTM D5151-19 (hole detection in medical gloves), ASTM D6124-06(2022) (residual powder), ASTM D5712-15(2020) (extractable protein analysis), ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-11:2017 (systemic toxicity), ISO 10993-23:2021 (irritation testing), and ISO 2859-1 (sampling procedures).

The subject device is substantially equivalent because it is identical to the predicate in intended use, material composition, design (color, texture, powder-free status, sizes), manufacturing specifications, and performance across all critical mechanical and safety properties (tensile strength, elongation, watertight integrity, biocompatibility). The sole meaningful difference—a stricter protein limit of <50 µg/dm² versus ≤200 µg/dm²—represents an enhanced safety feature rather than a fundamental design change. Non-clinical testing confirms the subject device meets or exceeds the predicate across all measured parameters, and biocompatibility studies demonstrate it is non-irritating, non-sensitizing, and safe.