(152 days)
The Powder free nitrile examination gloves (white, blue and black) 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.
Powder Free Nitrile Examination Gloves (White, Blue and Black)
The provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Nitrile Examination Gloves (White, Blue and Black)". It confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory provisions. However, it does not contain any information about:
- Acceptance criteria for device performance studies.
- Results of a study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established for training sets.
This document is a regulatory approval letter, not a study report detailing performance data. Therefore, I cannot generate the requested table and information based on the provided text.
§ 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.