(39 days)
Powder free 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.
powder free vinyl patient examination gloves, (Light Yellow) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes the 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves (Light Yellow)." As such, the information contained does not pertain to the development or validation of a medical AI device. Instead, it details the safety and effectiveness information for a physical medical device (examination gloves) compared to a predicate device.
Therefore, many of the requested sections about AI device validation criteria, such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable to this document.
Here's an analysis of the available information based on the provided text, focusing on the acceptance criteria and the study (or tests) proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard / Acceptance Criteria | Reported 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 Residual | ASTM standard D 5250-06 and D6124-01 |
§ 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.