(354 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 the patient and the examiner.
Non-Sterile, Powder-Free, Nitrile Examination Gloves with Lanolin and Vitamin E Coating, Blue
1. Table of acceptance criteria and the reported device performance:
| Characteristics | Acceptance Criteria (Standards) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from Pinholes | ASTM D 6319-10 and ASTM D 5151-06 (1000ml water test both before and after aging) | Meets |
| Powder-Free Residue | ASTM D 6319-10 and ASTM D 6124-06 (Maximum 2mg/glove) | Meets |
| Biocompatibility | Dermal Sensitization (as per ISO 10993-10:2002) | Not a contact skin sensitizer |
| Primary Skin Irritation Test | Not a primary skin irritant |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each test (e.g., separate sample sizes for physical properties, pinholes, etc.). However, it refers to compliance with ASTM standards, which would dictate the sample sizes and testing methodologies. The data provenance is from Ug Global Resources Sdn Bhd, based in Malaysia, indicating the tests were conducted by the manufacturer for their 510(k) submission. The type of study is retrospective, as it describes tests performed on existing glove samples to demonstrate compliance with standards.
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 to this type of device and study. The "ground truth" for glove performance is established by standardized, objective tests outlined in ASTM and ISO standards, not by expert consensus or interpretation of subjective data.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in medical imaging or clinical trial settings where there's subjective interpretation by experts. For glove testing, the results are quantitative measurements against predefined thresholds in the 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 information is not applicable. This is a submission for a medical device (examination gloves), not an AI algorithm or diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The ground truth for this device is based on objective measurements and performance criteria defined by international and national standards, specifically:
- ASTM D 6319-10: Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D 5151-06: Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D 6124-06: Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10:2002: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
These standards provide the methodology and acceptable limits for various properties like dimensions, physical properties, freedom from pinholes, powder residue, and biocompatibility.
8. The sample size for the training set:
This information is not applicable. This is not an AI/machine learning study that involves training and test sets. The glove's performance is evaluated against established standards through direct testing.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in 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.