(221 days)
A Vinyl examination glove , Powder Free, Clear( Non-Colored ) 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.
Vinyl Examination Glove, Powder Free, Non-Colored
I am sorry, but the provided text is a 510(k) premarket notification acceptance letter from the FDA regarding a "Vinyl Examination Glove, Powder Free, Non-Colored." This document does not contain information about acceptance criteria, study details, performance data, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML medical device.
The request asks for specific details related to the evaluation of an AI-powered medical device, such as:
- Acceptance criteria and reported device performance.
- Sample size and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC study results, if applicable.
- Standalone performance.
- Type of ground truth used.
- Training set sample size and ground truth establishment.
None of this information is present in the provided FDA letter for a VINYL EXAMINATION GLOVE. This device is a Class I medical device (patient examination glove) and not an AI/ML-based diagnostic or analytical tool. Evaluation for such devices primarily focuses on material safety, barrier integrity, and physical properties, not on algorithmic performance or expert consensus for interpretation.
§ 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.