(46 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, Colored (White)
The provided information describes a K100075 premarket notification for "Powder-free Vinyl Patient Examination Gloves, Colored (White)". This is a medical device subject to general controls and a substantial equivalence determination, not an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable because these types of studies are not typically conducted for this class of device.
However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | 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 D6124-06 |
§ 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.