SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)

SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are disposable patient examination gloves worn by examiners to prevent contamination between patient and examiner. The gloves are available in two product lines (AMERI-TUFF Series 4000 and AMERI-TOUCH Series 5000) across multiple sizes (XS to XXL) and have been tested for compatibility with chemotherapy drugs per ASTM D6978-05.

Both subject and predicate devices are blue, powder-free, nitrile exam gloves with identical physical properties (tensile strength ≥14 MPa before and after aging, elongation 500% min before aging and 400% after aging, thickness ≥0.05mm). The subject device adds two new sizes (XS and XXL for Series 4000; XS through XXL for Series 5000) and introduces a new product line (Series 5000) alongside the predicate's Series 4000. Dimensions comply with ASTM D6319-19, and all other material, structural, and biocompatibility characteristics remain identical.

ASTM D6319-19 (dimensions and physical properties), ASTM D5151-06 (watertightness/hole detection), ASTM D6124 (powder content), ASTM D412 (tensile strength and elongation), ASTM D6978-05 Reapproved 2019 (permeation by chemotherapy drugs), ISO 10993-10 (skin irritation and sensitization), ISO 10993-5 (cytotoxicity), ISO 10993-11 (acute systemic toxicity).

The subject device maintains identical technological characteristics, materials, manufacturing specifications, and regulatory classification to the predicate device K222898. Non-clinical performance testing demonstrates that all chemotherapy drug permeation times for Series 4000 are identical to the predicate, and Series 5000 achieves the same protective function despite slightly shorter breakthrough times for Carmustine and Thio-Tepa (still providing adequate clinical protection with warnings for drugs with breakthrough times <120 minutes). The addition of new sizes and a new product line does not alter the fundamental design, intended use, or safety profile, as all sizes comply with the same dimensional and performance standards.