(53 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.
Powdered Vinyl Examination Gloves
I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for Powdered Vinyl Examination Gloves, which confirms the device's substantial equivalence to a predicate device.
The clearance letter does not contain details about:
- Specific acceptance criteria for device performance (e.g., tensile strength, tear resistance, barrier integrity).
- Details of a study that proves the device meets any specific acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance, number or qualifications of experts, or adjudication methods.
- Any multi-reader, multi-case comparative effectiveness study or standalone algorithm performance.
- The type of ground truth used or how it was established.
This document focuses on regulatory clearance based on substantial equivalence, not on a detailed technical performance study.
§ 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.