(64 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00e4
The provided document refers to the 510(k) summary for "FUGUAN (Brand) Powder Free Vinyl Patient Examination Gloves". This is a medical device application for gloves, not a complex AI-powered diagnostic or therapeutic device. As such, the study design and acceptance criteria are focused on physical and biological properties of the gloves, rather than diagnostic performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or human-AI interaction in a clinical setting.
Therefore, the requested information categories typically applicable to AI/ML device studies (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not relevant to this specific product.
Here's a breakdown of the acceptance criteria and performance as described in the document, tailored to the nature of this device:
Acceptance Criteria and Device Performance for FUGUAN Powder Free Vinyl Patient Examination Gloves
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Physical Properties | ||
| Dimension | ASTM standard D 5250-00e4. | Meets |
| Physical Properties | ASTM standard D 5250-00e4. | Meets |
| Barrier Integrity | ||
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Chemical Properties | ||
| Powder Residual | ASTM standard D 5250-00e4 |
§ 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.