Sourcing Requirements
chemotherapy gloves that meets the following criteria ASTM D6978 Testing: Gloves must be tested for resistance to permeation by chemotherapy drugs according to the ASTM D6978-05 (2019) Standard Practice Permeation Resistance: The gloves must have a minimum Breakthrough Detection Time (BDT) for specific hazardous drugs (often tested against Carmustine, Thio Tepa, etc. ) Powder-Free Requirement: The FDA banned powdered patient examination gloves, including chemotherapy-rated gloves, due to health risks Thickness and Length: While ASTM D6319 often applies to examination gloves, chemotherapy gloves often have specific,, elevated, minimum thickness ( > 0.10 mm ) and length ( > 270 mm ) requirements for added protection Labeling: Packaging must clearly state that they are tested for use with chemotherapy drugs and list tested drugs, often using the classification of "medical gloves with chemotherapy labeling claims" FDA Class I Device: They are classified as Class I reserved medical devices requiring a 510(K) notification to ensure safety and effectiveness