(40 days)
The 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.
Nitrile Powdered patient examination glove
The provided text is a 510(k) Premarket Notification for Nitrile Powdered Examination Gloves. It details the device's characteristics, intended use, and a comparison to a predicate device, focusing on nonclinical data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM Standard D6319-10 | Meets |
| Physical Properties | ASTM Standard D6319-10 | Meets (Elongation 500%/500%, Tensile Strength 14MPa/14MPa for before/after aging) |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151-06 | Meets |
| Powder Residual | ASTM Standard D6124-06 | Meets (Results generated values below 10 mg/dm² of powder) |
| Biocompatibility: | ||
| Primary Skin Irritation | ISO 10993-10:2010 (in rabbits) | Gloves are non-irritating |
| Dermal Sensitization | ISO 10993-10:2010 (in guinea pig) | Gloves do not display any potential for sensitization |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test set that led to the "Meets" determination. It references ASTM and ISO standards for testing, which would outline the appropriate sample sizes and methodologies for each specific test (e.g., how many gloves were tested for pinholes, how many animals for biocompatibility).
The data provenance is from nonclinical testing conducted by the manufacturer (Northstar Healthcare Holdings) or a designated testing facility on their behalf, designed to demonstrate compliance with established standards. No specific country of origin or retrospective/prospective nature of the data is mentioned beyond the standards themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device is a patient examination glove. The "ground truth" for this type of device is established by compliance with standardized physical performance and biocompatibility tests, not by expert interpretation of images or clinical data. The standards (ASTM, ISO) themselves define the criteria for "ground truth" or acceptable performance.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, often with conflicting opinions, requiring a consensus mechanism. For the nonclinical testing of gloves, the results are quantitative measurements against predefined thresholds specified in the ASTM and ISO standards.
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
This is not applicable. This device is a physical medical device (examination glove), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or an AI system. Its performance is evaluated through physical and biocompatibility testing.
7. The type of ground truth used
The ground truth for this device is based on established industry standards (ASTM and ISO), which define objective, measurable criteria for physical properties (dimensions, tensile strength, elongation, freedom from pinholes, powder residual) and biological safety (biocompatibility). The tests measure these characteristics directly against the specified thresholds.
8. The sample size for the training set
This information is not applicable. This device is not an AI/ML device that requires a training set. Its performance is assessed through direct testing against predetermined criteria.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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.