(72 days)
A powder-free patient examination glove is a disposable device made of synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Class II powder-free patient examination glove 80LYZ, that meets all of the requirements of ASTM standard D 5250-00.
Here's a summary of the acceptance criteria and study information for the Bernard Technologies, Inc. Powder-Free Vinyl Examination Gloves, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Physical Properties | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Freedom from Holes | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Powder-Free | Meets ASTM D 5250-0 | Meets ASTM D 5250-0 |
| Biocompatibility | Pass Primary Skin Irritation | Passes |
| Pass Dermal Sensitization | Passes | |
| General Performance | Meet or exceed ASTM standard | Meets or exceeds ASTM standard |
| Labeling Claims | Meet labeling claims | Meets labeling claims |
| Pinhole AQL | Meet pinhole AQL from Freedom from Holes data | Meets pinhole AQL |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for the testing of the "Powder-Free Vinyl Examination Gloves." It refers to meeting the requirements of ASTM standard D 5250-00, which would dictate standard testing methodologies and sample sizes for glove performance. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission, not from a clinical study. The tests would be prospective in nature, as they are performed on the device being submitted for clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a patient examination glove, and the "ground truth" for its performance is established by objective physical and chemical testing against established standards (ASTM D 5250-00) and biocompatibility tests, not subjective expert assessment as would be common for diagnostic imaging or clinical decision support AI devices.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is determined by objective testing against a standard, not by expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. For examination gloves, the endpoints are primarily physical properties and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product (glove), not an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's performance is based on established industry standards (ASTM D 5250-00) for dimensions, physical properties, freedom from holes, and powder-free status. Additionally, biocompatibility testing results (Primary Skin Irritation in Rabbits and Repeated Patch Dermal Sensitization Test) served as ground truth for biological safety.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI or algorithm that relies on a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.