(142 days)
Powdered vinyl 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.
powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
This document is a 510(k) Premarket Notification summary for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It describes the device, its intended use, and its substantial equivalence to a predicate device.
Here's an analysis of the provided information, framed by your questions:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This submission is for a medical device (patient examination gloves) that is subject to performance standards rather than requiring complex algorithmic analysis or human reader studies. Therefore, most of your requested points regarding AI/algorithm performance, ground truth establishment, and expert involvement are not applicable to this type of device and submission.
The "acceptance criteria" here refer to the performance requirements outlined in recognized standards (like ASTM and FDA regulations) for patient examination gloves. The "study" proving the device meets these criteria refers to non-clinical testing performed by the manufacturer.
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-06 | Meets ( |
§ 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.