(83 days)
A Synthetic Vinyl Examination Glove, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free, Synthetic Vinyl Examination Gloves
The provided document is a 510(k) premarket notification letter for "Powder Free, Synthetic Vinyl Examination Gloves." It is a regulatory document from the FDA acknowledging a device's substantial equivalence to a legally marketed predicate device. This type of document does not contain information about acceptance criteria or specific studies to prove device performance against such criteria.
The letter focuses on regulatory compliance, product classification (Class I, Product Code LYZ), and general controls provisions of the Act. It states the intended use of the device: "A Synthetic Vinyl Examination Glove, is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
To answer your request, information regarding:
- Acceptance criteria and reported device performance
- Sample size and data provenance
- Number and qualifications of experts
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- Sample size and establishment of ground truth for the training set
would typically be found in the actual 510(k) submission document or supporting test reports, which are not included in the provided text. The provided document is the FDA's response letter, not the submission itself.
Therefore, I cannot provide the requested information based on the given input.
§ 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.