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510(k) Data Aggregation
(98 days)
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free
This document describes the acceptance criteria and study results for SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the length of the gloves | Min 230 mm for all sizes | Small: Pass, Medium: Pass, Large: Pass, X-Large: Pass |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the width of the gloves | Small: 80+/-10 mm, Medium: 95+/-10mm, Large: 110+/-10 mm, X-Large: 120+/-10 mm | Small: Pass, Medium: Pass, Large: Pass, X-Large: Pass |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min for all sizes | All sizes: Palm Pass, Finger Pass |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Physical properties - Tensile Strength) | To Determine the physical properties Tensile strength | Before Ageing: Tensile Strength 14Mpa Min for all sizes. After Ageing: Tensile Strength 14Mpa Min for all sizes. | All sizes: Pass (Both before and after ageing) |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application (Physical properties - Ultimate Elongation) | To Determine the physical properties Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizes. After Ageing: Ultimate Elongation 400% Min for all sizes. | Small, Medium, Large, X-Large: Pass (Both before and after ageing) |
| ASTM D5151-19 Standard Test Method for detection of holes in medical gloves | To determine the holes in the gloves | AQL 2.5 | Pass |
| ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Small, Medium, Large, X-Large: Residual Powder Content Pass |
| ISO 10993-10:2010 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation. | To determine the potential of the material to produce dermal irritation in Rabbits | Under the condition of study not an irritant | Under the condition of study not an irritant |
| ISO10993-10:2010 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done Skin sensitization. | To determine the skin sensitization potential of the material in Guinea Pig. | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity. | To evaluate the in vitro cytotoxic potential of the test item extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non cytotoxic | Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern. |
| ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity. | To determine the acute systemic toxicity potential of the test item extracts in Swiss Albino mice. | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test listed (e.g., number of gloves tested for length, width, etc.). However, the tests are conducted in accordance with ASTM and ISO standards, which typically specify sampling plans.
The data provenance is from non-clinical tests conducted for the SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free. The manufacturer and exporter is SRIRUNGRUANG GLOBAL CO., LTD, located in Thailand. The studies are prospective as they were conducted specifically for this 510(k) submission to demonstrate substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts or the establishment of ground truth in the context of clinical or diagnostic studies. The tests described are non-clinical, laboratory-based physical and biocompatibility assessments of the gloves. Therefore, the concept of "ground truth" established by experts, as it would be for diagnostic accuracy studies, is not applicable here. The "ground truth" for these tests is defined by the objective measurement criteria within the specified ASTM and ISO standards.
4. Adjudication Method for the Test Set
Not applicable. As noted above, these are non-clinical laboratory tests with objective pass/fail criteria based on established standards, not studies requiring expert adjudication of results.
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-assisted diagnostic device, nor is it a study involving human readers or cases. It is a submission for patient examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is based on the specified quantitative and qualitative requirements of the referenced ASTM and ISO standards, such as minimum length, tensile strength, maximum powder residue, and the absence of irritation or sensitization. For the biocompatibility tests that showed cytotoxicity but no systemic toxicity concern, the "ground truth" was established through additional testing to confirm the lack of systemic risk.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (examination gloves), not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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