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510(k) Data Aggregation
(28 days)
Powder free Latex Examination Gloves with Grape is 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 with Grape is disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
This document is a 510(k) summary for "Powderfree Latex Examination Gloves with Grape" submitted by PT. Shamrock Manufacturing Corp. It describes the device, its intended use, and its technological characteristics as a medical device.
Acceptance Criteria and Study for "Powderfree Latex Examination Gloves with Grape"
The acceptance criteria and performance data for the "Powderfree Latex Examination Gloves with Grape" are based on the ASTM D 3578-01ae2 Standard for Latex Examination Gloves. The document states that the gloves "meet or exceed the ASTM D 3578-01ae2 Standard" and also "meet FDA pinhole requirement" and "meet labeling claim."
The study that proves the device meets the acceptance criteria is a series of tests performed against the ASTM D 3578-01ae2 standard.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D 3578-01ae2, min.) | Reported Device Performance |
|---|---|---|
| Dimensions (all sizes) | ||
| Length (mm) | 220 (Small) | 220 (Small) |
| 230 (Medium, Large, X-Large) | 230 (Medium, Large, X-Large) | |
| Palm Width (mm) | 80 ± 10 (Small) | 80 ± 10 (Small) |
| 95 ± 10 (Medium) | 95 ± 10 (Medium) | |
| 111 ± 10 (Large) | 111 ± 10 (Large) | |
| 120 ± 10 (X-Large) | 120 ± 10 (X-Large) | |
| Thickness (mm) | 0.08 (Cuff) | 0.08 (Cuff) |
| 0.08 (Palm) | 0.08 (Palm) | |
| 0.08 (Fingertip) | 0.08 (Fingertip) | |
| Physical Properties | ||
| Tensile Strength (MPa) - Before Ageing | 18 MPa (min.) | 18 MPa (min.) |
| Tensile Strength (MPa) - After Ageing (70°C 168 hrs.) | 14 MPa (min.) | 14 MPa (min.) |
| Ultimate Elongation (%) - Before Ageing | 650 % (min.) | 650 % (min.) |
| Ultimate Elongation (%) - After Ageing (70°C 168 hrs.) | 500 % (min.) | 500 % (min.) |
| Pinhole Requirement | FDA Pinhole Requirement | Meets FDA Pinhole Requirement |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the test set. However, it indicates these are standard tests performed on manufactured batches. The data provenance is presumed to be from the manufacturer, PT. Shamrock Manufacturing Corp. in Indonesia, based on the contact information and factory location listed. The data is retrospective, as it refers to compliance with an existing standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided. The ground truth is established by the specifications defined in the ASTM D 3578-01ae2 standard itself, which is a consensus standard developed by industry experts.
4. Adjudication Method for the Test Set:
This information is not provided. Compliance with ASTM standards typically involves specified testing methodologies and acceptance sampling plans, not clinical adjudication by experts in the same way a medical image diagnosis might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is not applicable to the assessment of physical properties and barrier integrity of examination gloves.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Its performance is assessed through physical and chemical testing.
7. Type of Ground Truth Used:
The ground truth used is established industry standards and regulatory requirements, specifically:
- ASTM D 3578-01ae2 Standard
- FDA Pinhole Requirement
8. Sample Size for the Training Set:
Not applicable. As this is a manufactured physical product, there is no "training set" in the context of an AI/algorithm. Quality control and manufacturing processes ensure that gloves produced in bulk meet the standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. The "ground truth" for manufacturing quality is established by the ASTM standard and FDA requirements for medical gloves, which guide the manufacturing process and subsequent quality checks for each batch produced.
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