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510(k) Data Aggregation
(41 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder free Latex Examination Gloves
The provided document describes the acceptance criteria and performance data for "Powder Free Latex Examination Gloves" manufactured by PT. Haloni Jane.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (ASTM D 3578-05ae2 Standard) | Reported Device Performance (PT. Haloni Jane Gloves) |
|---|---|---|
| Dimensions | ||
| Length mm (min.) | 240 (for S, M, L sizes) | 240 (for S, M, L sizes) |
| 240 +/- 5 (for XL size) | 240 +/- 5 (for XL size) | |
| Palm Width mm (min.) | 80 (for Small) | 80 (for Small) |
| 95 (for Medium) | 95 (for Medium) | |
| 105 (for Large) | 105 (for Large) | |
| 110 +/- 10 (for X-Large) | 110 +/- 10 (for X-Large) | |
| Thickness Cuff mm (min.) | 0.1 | 0.1 |
| Palm mm (min.) | 0.1 | 0.1 |
| Finger Tip mm (min.) | 0.1 | 0.1 |
| Physical Properties | ||
| Tensile Strength | 14 Mpa (min) (Before ageing) | 14 Mpa (min) (Before ageing) |
| 14 Mpa (min) (After ageing at 70°C 168 hrs.) | 14 Mpa (min) (After ageing at 70°C 168 hrs.) | |
| Ultimate Elongation | 500 % (min.) (Before ageing) | 500 % (min.) (Before ageing) |
| 400 % (min.) (After ageing at 70°C 168 hrs.) | 400 % (min.) (After ageing at 70°C 168 hrs.) | |
| Pin Hole Requirement | Meets FDA pin hole requirement | Meets FDA pin hole requirement |
| Labeling Claim | Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the tests.
- The data provenance is prospective, as it describes the results of tests performed on the manufactured gloves. The country of origin of the manufacturer is Indonesia.
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 testing. The acceptance criteria are based on established industry standards (ASTM D 3578-05ae2) rather than expert interpretation of a ground truth in a clinical context.
4. Adjudication method for the test set:
- This information is not applicable. Adjudication methods are typically used in studies where there is subjective interpretation involved, such as reading medical images. For physical property testing of gloves, objective measurements against a standard are performed.
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 device is not an AI-assisted diagnostic tool; it is a physical medical device (examination gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This device is not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the performance of these gloves is defined by objective physical property measurements and adherence to regulatory standards (ASTM D 3578-05ae2 and FDA pin hole requirements). There is no expert consensus, pathology, or outcomes data used as ground truth for this type of product.
8. The sample size for the training set:
- This information is not applicable. As this is not a machine learning or AI device, there is no concept of a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable.
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