(48 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)
Class I powder free colored(green) latex examination gloves with aloe vera and protein labeling claim(50 microgram or less) ,80LYY, non-sterile meets all the requirements of ASTM standard D3578-00 and FDA 21 CFR 800.20.
This is an examination glove, not an AI/ML device. Hence, the requested information about AI/ML device studies and ground truth is not applicable.
However, I can provide the acceptance criteria and performance of the glove:
Acceptance Criteria and Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-00 | Meets |
| Physical Properties | ASTM D 3578-00 | Meets |
| Freedom from Pinholes | ASTM D 3578-00; FDA 21 CFR 800.20 | Meets (AQL 1.5) |
| Powder Free | ASTM D 6124-97 |
§ 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.