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510(k) Data Aggregation
(78 days)
The vinyl examination glove is intended to be worn on the hands of examination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The proposed device is a powder free vinyl patient examination glove, provided as nonsterile and disposable device. The proposed device is provided with clear color. There are four sizes: small, medium, large and extra-large as options.
The provided document describes the acceptance criteria and performance data for Vinyl Examination Gloves, a Class I medical device. It does not pertain to an AI/ML-based medical device. Therefore, many of the requested fields regarding AI/ML device testing (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable.
Here's the information extracted from the document, focusing on the device performance and acceptance criteria for these physical examination gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| ASTM D5250 (Physical Dimensions Test) | To verify physical dimensions | - Length: ≥ 230mm - Width (Small): 85±5mm - Width (Medium): 95±5mm - Width (Large): 105±5mm - Width (Extra-Large): 115±5mm - Thickness (Finger): ≥ 0.08mm - Thickness (Palm): ≥ 0.08mm | Pass |
| ASTM D5250 (Physical Properties - Before Aging) | To determine tensile strength and ultimate elongation before aging | - Tensile Strength: ≥ 11MPa - Ultimate Elongation: ≥ 300% | Pass |
| ASTM D5250 (Physical Properties - After Aging) | To determine tensile strength and ultimate elongation after aging | - Tensile Strength: ≥ 11MPa - Ultimate Elongation: ≥ 300% | Pass |
| ASTM D5151 | Freedom from pinholes | Meets the ASTM D5151 Test for AQL 2.5 requirements | Pass |
| ASTM D6124 | Powder Residue | Meets ASTM D6124 requirements: < 2.0mg | Pass |
| ISO 10993-10 | To determine if the device material is an irritant | Non-irritating | Under the conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | To determine if the device material is a sensitizer | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ISO 10993-11 | To determine if the device material extracts pose a systemic toxic response | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test mentioned (e.g., number of gloves tested for physical properties, pinholes, or biocompatibility). The tests are based on established ASTM and ISO standards, which typically specify sampling plans.
- Data Provenance: The tests were conducted internally by the manufacturer, Guangdong Kingfa Sci.& Tech.Co., Ltd., in China. The documentation implies these were prospective tests conducted on the manufactured product 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
Not applicable. This is not an AI/ML device requiring expert interpretation of results. The "ground truth" for the performance of examination gloves is based on objective, quantifiable physical and chemical properties measured according to international standards (ASTM, ISO).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring human adjudication of qualitative data.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11). For example, tensile strength and elongation are measured directly, and biocompatibility is assessed through standardized in-vivo and in-vitro tests with specific endpoints.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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