(60 days)
A patient examination glove is a disposable intended for medical purposes A patient examiner's hand or finger to prevent contamination between patient and examiner
Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less)
Here's an analysis of the provided 510(k) summary, breaking down acceptance criteria and the study information as requested.
The provided document describes Sterile, powder-free latex examination gloves with polymer coating and protein claim (50 micrograms or less). It is a submission for a 510(k) premarket notification, which is a process to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on non-clinical performance data and does not typically involve extensive human clinical trials or AI performance evaluations as described for complex AI/ML-based medical devices.
Therefore, many of the requested points related to AI/ML studies (test sets, ground truth establishment, MRMC studies, standalone performance, training sets) are not applicable to this type of device and submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-2001-ae2 | Meets |
| Physical Properties | ASTM D 3578-2001-ae2 | Meets |
| Freedom from pinholes | ASTM D 3578-2001-ae2 | Meets |
| Powder Free Residue | ASTM D 6124-2001 | $\le$ 2 mg/glove |
| Protein Level | ASTM D 5712-99 | $ |
§ 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.