(106 days)
The powder free vinyl patient examination glove, Clear (non-colored) 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. It is sold as non sterile.
Powder free vinyl patient examination gloves, clear (non-colored), non sterile that meets all of the requirements of ASTM standard D 5250-06, except for sterility requirements.
The provided PDF describes the details of a 510(k) submission for "Powder Free Vinyl Patient Examination Gloves". This document is for a medical device (gloves) and not an AI/ML powered device. Therefore, many of the typical AI/ML study components (like sample size for test/training set, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.
However, I can extract the acceptance criteria and the study that proves the device meets them as described in the document.
Acceptance Criteria and Reported Device Performance
The device is a "Powder Free Vinyl Patient Examination Glove" and its performance is assessed against recognized consensus standards for patient examination gloves.
| Description | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | Meets ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | Meets ASTM D5151-06 (or 21 CFR 800.20 for predicate) | Meets ASTM D5151-06 |
| Residue Powder | Meets ASTM D6124-06 | Meets ASTM D6124-06 |
| Cytotoxicity | Passes ISO 10993-5 | Passes |
| Primary Skin Irritation | Passes ISO 10993-10 | Passes |
| Dermal Sensitization | Passes ISO 10993-10 | Passes |
Study Information (Non-AI/ML Device Specifics):
Since this is for a patient examination glove and not an AI/ML device, the following points typical for AI/ML studies are not relevant or applicable here. The "study" here refers to the physical and biocompatibility testing conducted on the gloves to ensure they meet the established standards.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. The testing involved physical and chemical properties of the glove samples according to the specified ASTM and ISO standards. The document doesn't provide specific sample sizes for these tests, but they are implied to follow the standard testing protocols. Data provenance is implied to be from the manufacturer's testing of their product.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product like a glove is determined by measurement against physical standards in a laboratory setting, not by expert consensus in a clinical scenario.
- Adjudication method for the test set: Not applicable. Performance is determined by direct measurement against quantitative standards.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used: For this device, the "ground truth" is defined by established international consensus standards (ASTM and ISO) for physical properties (dimensions, pinholes, physical strength) and biocompatibility (cytotoxicity, skin irritation, sensitization).
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.