Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff

This device is a sterile, disposable, powder-free nitrile examination glove in blue color, designed to be worn by healthcare examiners to prevent contamination between patient and examiner. The gloves are specifically tested for use with chemotherapy drugs and fentanyl citrate according to ASTM D6978. Two variants are cleared: a standard version and an extended cuff version (minimum 260mm length vs. 230mm).

Both subject devices are single-use, sterile, ambidextrous nitrile gloves with identical design and materials to the predicate. Key differences include: subject devices meet ASTM D6319-19(2023) standards versus predicate's D6319-10(2015); subject devices tested against 24 chemotherapy drugs plus fentanyl versus predicate's limited drug panel; extended cuff variant has 260mm minimum length versus predicate's 230mm. All physical properties, biocompatibility results, and sterilization methods (radiation, 10⁻⁶ SAL) are equivalent or comparable.

ASTM D5151-19(2023) for hole detection; ASTM D6124-06(2017) for residual powder; ASTM D6319-19(2023) for dimensions, tensile strength, and elongation; ASTM D6978 for chemotherapy drug permeation resistance; ISO 10993-23 for skin irritation; ISO 10993-10 for dermal sensitization; ISO 10993-11 for acute systemic toxicity.

The devices are substantially equivalent because they use identical materials (nitrile), design (single-use, sterile, powder-free, ambidextrous), and manufacturing method (radiation sterilization) as the predicate K201531. All biocompatibility and physical property test results are equivalent or better. While the subject devices were tested against a broader panel of chemotherapy drugs (24 vs. the predicate's smaller set) and achieved comparable or superior barrier performance (same minimum breakthrough times for key agents like Carmustine and Thiotepa), this expanded testing demonstrates equivalent or greater safety and effectiveness. The extended cuff variant is merely a dimensional variation (260mm vs. 230mm) that does not affect safety or performance, as all devices meet applicable ASTM standards. The expanded drug testing actually strengthens the equivalence argument by demonstrating robust permeation resistance across a more comprehensive drug profile.