(70 days)
A patient examination Vinyl Powdered Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent the examination in the ad examiner intended for medical purpose and examiner.
Vinyl Powdered Examination Glove
The provided text is a 510(k) clearance letter from the FDA for a Vinyl Powdered Examination Glove. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth details for an AI/device.
Instead, the document primarily:
- Confirms the substantial equivalence of the device to pre-existing legally marketed devices.
- Outlines post-market regulatory requirements for the manufacturer.
- Specifies the "Indications for Use" for the glove.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study details based on the provided input. This document is a regulatory approval letter, not a technical report or clinical study summary for an AI/device.
§ 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.