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510(k) Data Aggregation
(153 days)
A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device. Latex Surgeon's Gloves Powdered is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, per standard ASTM D3577-096', the rubber surgical gloves classification is: "Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powdered Latex Surgeon's Gloves, and variations of different size. All variations share the same color, creamy white. The proposed device is provided Gamma radiation sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.
The provided text describes a 510(k) premarket notification for a medical device: "TULIP Natural Rubber Latex Surgeon's Glove (Powdered)". This submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness. Therefore, the "study" described is a series of bench tests and adherence to recognized standards, not a clinical trial in the traditional sense.
Here's an analysis of the acceptance criteria and the "study" that proves the device meets them, based on your requested information categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3577-09e1 | |
| Palm width (Size 6) | 76 ± 6 mm | 73-80 mm |
| Palm width (Size 6½) | 83 ± 6 mm | 80-85 mm |
| Palm width (Size 7) | 89 ± 6 mm | 86-90 mm |
| Palm width (Size 7½) | 95 ± 6 mm | 92-98 mm |
| Palm width (Size 8) | 102 ± 6 mm | 100-104 mm |
| Palm width (Size 8½) | 108 ± 6 mm | 106-111 mm |
| Length | ≥ 265mm min | 273-297 mm |
| Thickness fingertip | ≥ 0.10mm min | 0.22-0.31 mm |
| Thickness palm | ≥ 0.10mm min | 0.22-0.30 mm |
| Thickness cuff | ≥ 0.10mm min | 0.20-0.30 mm |
| Physical Properties | ASTM Standard D3577-09e1 | |
| Tensile Strength (Before Aging) | 24 Mpa | 26-30 Mpa |
| Tensile Strength (After Aging) | 18 Mpa (min) | 21-25 Mpa (min) |
| Stress at 500% elongation | 5.5 Mpa (MAX) | 3.5-4.0 Mpa |
| Ultimate elongation (Before Aging) | 750% | 800-890% |
| Ultimate elongation (After Aging) | 560% (min) | 650-780% |
| Freedom from pinholes | 21 CFR 800.20 | Passed Standard Acceptance Criteria |
| Powder Amount | D6124-06 (Reaffirmation 2011) | Meets (≤ 15 mg/dm²) |
| Protein Level | ASTM Standard D5712-10 | Meets (≤ 200 µg/dm²) |
| Biocompatibility | ISO 10993-10: 2010-08-01 (Primary Skin Irritation | |
| and Dermal Sensitization) | Passes (Not a Primary Skin Irritation, | |
| Not a Dermal Sensitization) | ||
| Sterilization Validation | ISO 11137-1:2006 | Sterility Assurance Level (SAL) of 10⁻⁶ |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, pinholes, etc.). It refers to adherence to the methodologies outlined in the referenced ASTM and ISO standards for these tests. These standards typically specify minimum sample sizes for their respective test methods.
The data provenance is not specified beyond being "bench tests" conducted by the manufacturer, Shanghai Jinxiang Latex Products Co., Ltd. The country of origin of the data would therefore be China, where the manufacturer is located. The nature of these tests (bench testing) makes them prospective in the context of generating data for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for glove performance is established by the accepted industry standards (ASTM, ISO, and FDA regulations) themselves. The testing involves objective measurements against these predefined numerical and qualitative criteria, not subjective expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against established standards, not a consensus-based adjudication process.
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/software as a medical device (SaMD) and therefore no MRMC study or AI-related comparative effectiveness was performed or required.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (surgical glove), not an algorithm or software. "Standalone performance" in this context refers to the glove's physical and biological properties as measured by the bench tests, without human intervention in the performance of the device itself (only in its use).
7. The Type of Ground Truth Used
The "ground truth" used is defined by adherence to published and recognized national and international standards (ASTM and ISO) and FDA regulations (21 CFR 800.20). These standards specify acceptance criteria for various physical, chemical, and biological properties of surgical gloves. The tests performed are designed to objectively measure these properties against those established "ground truths."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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