(216 days)
This is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Non-sterile, Powder-free Nitrile Examination Glove with Polymer coating, Aloe and Vitamin E. Blue.
The provided text describes a 510(k) summary for a Nitrile Examination Glove, not a medical imaging AI device. Therefore, it does not contain information related to acceptance criteria, study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) typically associated with the development and validation of AI models for medical imaging.
The document focuses on demonstrating substantial equivalence of a new glove product to existing predicate devices based on material, intended use, physical properties, and biocompatibility.
Therefore, I cannot extract the requested information as it is not present in the provided text.
If you have a document describing an AI device for medical imaging, please provide that, and I will be happy to extract the relevant details.
§ 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.