(86 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 5250-06.
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of an AI/ML powered device. The information requested (acceptance criteria, specific study details for AI/ML, sample sizes for training/test sets, expert adjudication methods, MRMC studies, etc.) is typically associated with AI/ML device submissions, which are significantly different in scope and requirements from a Class I glove submission.
Therefore, the requested information, which is primarily relevant to AI/ML powered devices, is not applicable and not available in this submission for the following reasons:
- Device Type: The device is a "Powder Free Vinyl Patient Examination Glove," a physical, low-risk medical device. It does not involve any imaging, diagnostic algorithms, or AI/Machine Learning components.
- Regulatory Pathway: This is a 510(k) submission for a Class I device, which relies heavily on demonstrating conformance to established standards (like ASTM) and substantial equivalence to a legally marketed predicate device. The detailed performance studies typical for AI/ML devices, especially those requiring complex ground truth establishment and human-in-the-loop assessments, are not required for this type of device.
- Nature of "Performance": For gloves, "performance" relates to physical properties, freedom from defects (like pinholes), and biocompatibility, as opposed to diagnostic accuracy or clinical decision support.
However, I can extract the acceptance criteria and the device performance as reported in the summary for the glove, which is the closest equivalent to your request within the provided text.
Here is the information based on the provided K102817 document, adapted to the context of a medical glove:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | 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 | Meets |
| 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.