(90 days)
This 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 (21CFR 880.6250).
powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-004.
The provided text is a 510(k) Premarket Notification Summary for Powdered Vinyl Patient Examination Gloves, White (Non-colored). This type of document is about demonstrating substantial equivalence to a predicate device, not necessarily proving novel clinical effectiveness or advanced AI performance. As such, the requested information regarding AI device acceptance criteria, expert adjudication, MRMC studies, and standalone algorithm performance, as well as specific details about training and test sets common for AI/ML device submissions, are not applicable to this traditional medical device submission.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical tests conducted to ensure the gloves meet established standards for similar devices.
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-00e4 | Meets |
| Physical Properties | ASTM standard D 5250-00e4 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Amount | ASTM standard D 5250-00e4 | 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.