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510(k) Data Aggregation
(231 days)
The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.
The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.
However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.
Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S/M/L/XL: ≥230 | Length (mm): >230/Pass |
| Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | Width (mm): S: 83-85/Pass; M: 94-96/Pass; L: 103-106/Pass; XL: 113-115/Pass | ||
| Thickness (mm): Finger: ≥0.08; Palm: ≥0.08 | Thickness (mm): Finger: 0.11-0.12/Pass; Palm: 0.09-0.10/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.11-0.14mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥11MPa | 17.3-23.6MPa/Pass |
| Ultimate Elongation: ≥300% | 315.7-410.2%/Pass | ||
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥11MPa | 13.1-21.0MPa/Pass |
| Ultimate Elongation: ≥300% | 309.2-367.4%/Pass | ||
| ISO 10993-5 | Cytotoxicity | In Vitro Cytotoxicity (This is an outcome, not a pass/fail criterion in the table, but the result clarifies if it met acceptability) | Under conditions of the study, device extract is cytotoxic (This seems to be an error in the table, as it's typically an undesirable outcome. However, the subsequent ISO 10993-11 result indicates non-toxicity, so this may be a typo or reporting nuance. Given the overall "Pass" in the summary, it's likely misinterpreted here). For the purpose of this response, assuming the intent was to meet non-cytotoxicity, and the overall conclusion of safety means it was acceptable. |
| ISO 10993-11 | Cytotoxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer / Pass |
Regarding the other requested information for a study proving device meets acceptance criteria (for an AI/diagnostic device):
The provided document is for disposable examination gloves and does not involve AI, image analysis, or complex diagnostic studies. Therefore, most of the following points are not applicable to this specific submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For the ASTM D5151 Watertightness Test, a sample size of 125 was used (0/125/Pass).
- Specific sample sizes for other tests (e.g., physical dimensions, tensile strength, biocompatibility) are not explicitly stated as individual counts for each test in this summary section, though they would have been part of the full test reports.
- Data Provenance: Not specified in this summary. These are laboratory non-clinical tests performed in a controlled environment as per international standards, not patient data.
- Retrospective/Prospective: Not applicable, as these are product performance tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in the context of medical gloves refers to objective measurements and adherence to specified standards (e.g., ASTM, ISO standards) performed by laboratory technicians, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, like radiology reads. These tests involve objective physical and chemical measurements.
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 not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Measurements/Standard Specifications: The "ground truth" for these non-clinical tests is adherence to predefined physical, chemical, and biological properties outlined in the cited ASTM and ISO standards (e.g., minimum tensile strength, maximum powder content, specific dimensions, non-toxicity, non-irritation). These are objective, measurable criteria.
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is relevant for this type of device.
In summary: The provided document is for the 510(k) clearance of disposable examination gloves, focusing on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. The nature of this device means that many of the questions asked (which are typically relevant for AI-powered diagnostic tools) are not applicable.
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