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510(k) Data Aggregation
(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.
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(41 days)
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