(14 days)
A 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.
VINYL EXAMINATION GLOVE, POWDER-FREE, WHITE
This document is a 510(k) premarket notification letter from the FDA regarding a Vinyl Examination Glove. It is not a study report or clinical trial. Therefore, it does not contain any information about:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This letter solely communicates the FDA's determination of substantial equivalence for the Vinyl Examination Glove to legally marketed predicate devices, allowing it to proceed to market subject to general controls. It does not provide detailed performance data or study specifics.
§ 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.