Regulatory actions under existing authority, such as seizures and detentions of specific glove lots, were handled on a case by case basis. Single sampling will be used for lots less than or equal to 1200 gloves, while multiple sampling will be used for larger lots. Surgeon's gloves and patient examination gloves that contain holes are adulterated devices. Adulteration will be determined on a lot by lot basis for enforcement purposes. Complaints for the seizure of devices should not include allegations of shipment in interstate commerce because allegations of interstate commerce are not required to support seizure of devices.
Health professionals rely on examination gloves to prevent the transmission and spread of disease.
This has become increasingly important in light of the current AIDS epidemic. Five single and four multiple sample examination plans are presented below for various lot sizes. Examination may cease when a lot is determined to be violative. 38 Six single and three multiple sample examination plan are presented below for various lot sizes. Examination may cease when a lot is determined to be violative.