(38 days)
Synthetic Vinyl Examination Glove, Powder Free 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.
Synthetic Vinyl Examination Gloves, Powder-Free
I am sorry, but the provided text is a letter from the FDA regarding the 510(k) premarket notification for "Synthetic Vinyl Examination Gloves, Powder-Free." It primarily discusses the regulatory classification of the device and general compliance requirements.
This document does not contain any information about:
- Acceptance criteria for device performance
- A study proving the device meets acceptance criteria
- Sample sizes for test or training sets
- Data provenance
- Ground truth establishment or type
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance studies
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them 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.