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510(k) Data Aggregation
(43 days)
A powder free examination glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination on examiner's hand: to prevent of ・・・・・・・・・・・・・・・ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ー …… '
Powder free Latex 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, a 510(k) summary for PT. Shamrock Manufacturing Corporation's Powder Free - Latex Examination Gloves, describes the device and its performance data. However, it does not include detailed acceptance criteria or a study that specifically "proves" the device meets these criteria in the typical sense of a clinical or comparative effectiveness study for AI/medical imaging devices.
Instead, this document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Class I Examination Gloves 80 L YY meeting ASTM D 3578-99) by presenting performance data that meets established industry standards.
Here's an analysis based on the information provided, framed to address your requested points where applicable, and highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D 3578-99) | Reported Device Performance (Powder Free - Latex Examination Gloves) |
|---|---|---|
| Dimensions (Length mm min.) | 280 (for all sizes) | 280 (for Small, Medium, Large, X-Large) |
| Dimensions (Palm Width mm) | Small: 80±10, Medium: 95±10, Large: 111±10, X-Large: ≥ 110 | Small: 80±10, Medium: 95±10, Large: 111±10, X-Large: ≥ 110 |
| Thickness (Cuff mm min) | 0.20 | 0.20 |
| Thickness (Palm mm min) | 0.20 | 0.20 |
| Thickness (Finger Tip mm) | 0.20 | 0.20 |
| Tensile Strength (Before ageing) | : 21 Mpa (min) | : 21 Mpa (min) |
| Tensile Strength (After ageing at 70°C 168 hrs.) | : 18 Mpa (min) | : 18 Mpa (min) |
| Ultimate Elongation (Before ageing) | : 750 % (min.) | : 750 % (min.) |
| Ultimate Elongation (After ageing at 70°C 168 hrs.) | : 700 % (min.) | : 700 % (min.) |
| Pin Hole Requirement | Meets FDA pin hole requirement | Meets FDA pin hole requirement |
| Labeling Claim | Meets ASTM D 3578-99 | Meets labeling claim |
Explanation: The "acceptance criteria" for this device are the specifications outlined in the ASTM D 3578-99 standard and FDA pin hole requirements. The reported device performance matches these criteria exactly, as stated in section (6) "Technological characteristic of the gloves" and (9) "Non-clinical data."
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size used for testing these physical and performance characteristics. The testing methodology for ASTM standards would dictate this, but it is not elaborated upon in this 510(k) summary. The data provenance is not explicitly stated in terms of country of origin for the testing, but the manufacturer is PT. Shamrock Manufacturing Corporation in Indonesia. The testing would be considered retrospective as it likely occurred during product development and validation prior to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable in the context of this device and document. "Ground truth" in the sense of expert consensus for medical imaging interpretations (like a radiologist reading an image) is not relevant here. The ground truth for glove performance is established by objective measurements against a recognized standard (ASTM D 3578-99).
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" or "3+1" are used for resolving disagreements among human readers or expert panels, typically in subjective assessment tasks. The testing of gloves involves objective measurements against a standard, not subjective interpretations requiring adjudication.
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 a medical device (latex examination gloves), not an AI diagnostic or assistive imaging device. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device is based on objective measurements against established engineering and material science standards (ASTM D 3578-99) and regulatory requirements (FDA pin hole requirement). This is a form of performance standard ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning models, not for manufacturing specifications of gloves.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device. The standards (ASTM D 3578-99) were established through a consensus process by relevant industry and scientific bodies over time.
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