(38 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, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0004
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The provided document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device and its compliance with relevant standards rather than a study for an AI/ML powered device. Therefore, many of the requested fields for AI/ML device studies are not applicable.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimension (ASTM D 5250-00e4) | Meets |
| Physical Properties (ASTM D 5250-00e4) | Meets |
| Freedom from pinholes (21 CFR 800.20) | Meets |
| Powder Residual (ASTM D 5250-00e4 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.