(35 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder Free Clear Synthetic Vinyl Examination Gloves
This document is a 510(k) clearance letter for Powder Free Clear Synthetic Vinyl Examination Gloves, not a study report for an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted from the provided text.
The document discusses the substantial equivalence of the gloves to legally marketed predicate devices and outlines general regulatory requirements for medical devices. It does not contain any information about:
- Acceptance criteria for an AI/ML algorithm.
- Performance metrics of an AI/ML device.
- Sample sizes for test or training sets for AI/ML.
- Data provenance or ground truth establishment for AI/ML.
- Expert involvement in AI/ML performance evaluation.
- MRMC studies for AI/ML.
- Standalone performance or human-in-the-loop performance of AI/ML.
§ 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.