(130 days)
A Nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These specialty gloves were tested for use with Chemotherapy drugs and Fentanyl.
POWDER FREE NITRILE EXAMINATION GLOVE - Blue, NON STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
The provided document is a 510(k) premarket notification letter from the FDA for a Powder Free Nitrile Examination Glove. It does not contain information about an AI/ML device or a study proving its performance against specific acceptance criteria in the context of AI.
The document discusses the regulatory classification of the glove, its intended use (preventing contamination between patient and examiner), and its testing for use with chemotherapy drugs and Fentanyl. The table provided lists "Breakthrough Detection Time in Minutes" for various chemotherapy drugs and Fentanyl Citrate, which are performance metrics for the glove's barrier properties, not for an AI/ML device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the document does not pertain to an AI device.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.