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510(k) Data Aggregation
(40 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
Here's a breakdown of the acceptance criteria and study information based on the provided text:
Device Name: Powder free Latex Examination Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D 3578-05) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Length (min.) | 240 mm for all sizes (S, M, L, XL) | 240 mm (min.) |
| Palm Width (min) | 80 mm (S), 95 mm (M), 100 mm (L), 110 mm (XL) | 80 mm (S), 95 mm (M), 100 mm (L), 110 mm (XL) |
| Thickness (min) - Cuff | 0.1 mm for all sizes | 0.1 mm |
| Thickness (min) - Palm | 0.1 mm for all sizes | 0.1 mm |
| Thickness (min) - FingerTip | 0.1 mm for all sizes | 0.1 mm |
| Physical Properties | ||
| Tensile Strength (Before ageing) | 18 MPa (min) | 18 MPa (min) |
| Ultimate Elongation (Before ageing) | 650 % (min.) | 650 % (min.) |
| Tensile Strength (After ageing at 70°C 168 hrs.) | 14 Mpa (min) | 14 Mpa (min) |
| Ultimate Elongation (After ageing at 70°C 168 hrs.) | 500 % (min.) | 500 % (min.) |
| FDA pin hole requirement | Meets requirement | Meets FDA pin hole requirement |
| Labeling claim | Meets requirement | Meets labeling claim |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set during the performance evaluation for the "Powder Free Latex Examination Gloves." It refers to the ASTM D 3578-05 standard, which would typically define the sampling plan for such tests.
The data provenance is not explicitly mentioned beyond the manufacturer being PT. Shamrock Manufacturing Corpora in Medan, North Sumatra, Indonesia. The testing itself would have been conducted to meet the ASTM standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical product (examination gloves), not an AI/software device that requires expert-established ground truth for diagnosis/interpretation. The "ground truth" here is defined by objective physical and chemical properties measured against a standard (ASTM D 3578-05).
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations, not objective measurements of physical properties.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is a medical device (gloves), not an AI system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a medical device (gloves), not an AI system. Even if it were an AI system, "standalone" in this context refers to AI performance without human intervention, which isn't relevant for a physical product.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device is based on objective physical and chemical standards as defined by ASTM D 3578-05 (Standard Specification for Rubber Examination Gloves) and FDA pinhole requirements.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/machine learning system, so there is no concept of a "training set" in the traditional sense for algorithm development. The manufacturing process would involve internal quality control and production monitoring, but not a "training set" like an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in #8. The "ground truth" for manufacturing would be established by the specifications of the ASTM standard.
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