(76 days)
A 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.
Non-Sterile, powdered latex examination gloves.
The acceptance criteria for the "Non-sterile, powdered latex examination gloves" and the study proving adherence to these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | ASTM D 3578-05 | Meets |
| Physical Properties | ASTM D 3578-05 | Meets |
| Freedom from pinholes | ASTM D 3578-05 | Meets |
| Powdered Residue | ASTM D 3578-05 | Meets |
| Protein Level | ASTM D 3578-05 | Meets |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits | Passes |
| Biocompatibility (Guinea Pig Sensitization) | Guinea Pig Sensitization | Passes |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., freedom from pinholes, physical properties, etc.). It refers to "The performance test data of the non-clinical tests that support a determination of substantial equivalence" suggesting that tests were conducted.
The data provenance is not explicitly mentioned as country of origin but implies the tests were conducted by the manufacturer, Siam Sempermed Corp., Ltd, based in Thailand. The nature of the tests (e.g., ASTM standards for physical properties, animal studies for biocompatibility) indicates that these were likely prospective laboratory tests conducted to meet established standards for medical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" for these tests is implicitly defined by the ASTM standards and the biological test methodologies. For example, "Passes" for Biocompatibility (Primary Skin Irritation in Rabbits) signifies that the results fell within the acceptable parameters defined by the test method, rather than being determined by expert consensus on specific device defects.
4. Adjudication method for the test set
Not applicable. The tests mentioned (e.g., ASTM D 3578-05, Primary Skin Irritation in Rabbits) are objective laboratory or animal studies with clear pass/fail criteria based on predefined specifications or biological responses. They do not involve human interpretation or adjudication in the sense of consensus building among experts.
5. 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 device is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As this is a physical medical device, there is no algorithm or AI component to evaluate in a standalone capacity.
7. The type of ground truth used
The ground truth used for evaluating the device's performance is based on:
- Established Industry Standards: ASTM D 3578-05 for various physical characteristics (dimensions, physical properties, freedom from pinholes, powdered residue, protein level).
- Standardized Biological Test Methods: "Primary Skin Irritation in Rabbits" and "Guinea Pig Sensitization" for biocompatibility.
These methods define the objective criteria that the device must meet to be considered acceptable.
8. The sample size for the training set
Not applicable. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.
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.