(198 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner`s hands or finger to prevent contamination between patient and examiner.
A Powder-Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.
Here's a breakdown of the acceptance criteria and study information for the Powder Free Vinyl Patient Examination Gloves based on the provided 510(k) summary:
This device is a Class I medical device (21 CFR 880.6250) and a patient examination glove, which is generally subject to general controls and performance standards, rather than an AI/software device that would require the typical studies you've asked about (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts, training set details). The "studies" for this device relate to physical and biological testing to ensure safety and conformance to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Test Performed | Reported Device Performance/Result |
|---|---|---|
| ASTM D5250-06 (Dimension) | Dimensional testing | Meets requirements |
| ASTM D5250-06 (Physical Property) | Physical property testing | Meets requirements |
| ASTM D5151-06 (Free of Pinhole) | FDA 1000 ml Water Fill Test (AQL 2.5, G-1) | Meets requirements |
| ASTM D6124-06 (Residual Powder) | Residual powder testing |
§ 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.