(174 days)
Powder Free Vinyl Patient Examination Gloves, Colored (White) 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) that meets all of the requirements of ASTM standard D 5250-06.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Vinyl Patient Examination Gloves, Colored (White)".
This product is a medical device (patient examination gloves), which falls under a different regulatory and testing paradigm than AI/software-as-a-medical-device (SaMD). Therefore, many of the requested categories related to AI/SaMD studies (e.g., sample size for test/training sets, adjudication methods, MRMC studies, and ground truth for AI) are not applicable.
However, I will provide the information based on the provided text, indicating "Not Applicable" where appropriate for an AI/SaMD context.
Acceptance Criteria and Study for "Powder Free Vinyl Patient Examination Gloves, Colored (White)"
| Information Category | Detail Provided in Document |
|---|---|
| 1. Table of Acceptance Criteria and Reported Performance | |
| Characteristics | Acceptance Criteria (Standard) |
| Dimension | ASTM standard D 5250-06 |
| Physical Properties | ASTM standard D 5250-06 |
| Freedom from Pinholes | 21 CFR 800.20 |
| 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.