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510(k) Data Aggregation
(88 days)
The Disposable Nitrile Examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Examination gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The document describes the acceptance criteria and the results of the non-clinical performance testing for the "Disposable Nitrile Examination gloves."
1. Table of Acceptance Criteria and Reported Device Performance:
| No. | Name of the Test Methodology / Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| 1 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Skin Sensitization Test) | Provided grades less than 1, otherwise sensitization. | All grades are 0. All animals survived and no abnormal signs were observed. |
| 2 | ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Skin Irritation Test) | If the primary irritation index is 0-0.4, the response category is Negligible. | The primary irritation index is 0. The response was categorized as negligible. |
| 3 | ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | The viability (%) of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viability (%) of 100% test article extract is 86.5%. The proposed device has no potential toxicity to L-929 in the MTT method. |
| 4 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Powder residue limit of 2.0 mg. | 0.16 mg |
| 5 | ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves. | Samples number: 125 gloves, AQL: 2.5 (ISO 2859), Criterion $\le$ 7 gloves for water leakage. | No glove water leakage found. |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - S) | Width 80 $\pm$ 10mm, Length $\ge$ 220 mm | Width: 83-86 mm, Length 253-266 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - M) | Width 95 $\pm$ 10mm, Length $\ge$ 230 mm | Width 96-98 mm, Length 243-262 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - L) | Width 110 $\pm$ 10mm, Length $\ge$ 230 mm | Width 106-110 mm, Length 247-254 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Dimensions - XL) | Width 120 $\pm$ 10mm, Length $\ge$ 230 mm | Width 112-118 mm, Length 245-252 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Thickness) | Finger $\ge$ 0.05 mm, Palm $\ge$ 0.05 mm | Finger 0.09-0.11 mm, Palm 0.08-0.11 mm |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Physical properties - Before Aging) | Tensile strength $\ge$ 14MPa, Ultimate Elongation $\ge$ 500% | Tensile strength 15.7-17.7 MPa, Ultimate Elongation 532.284% - 552.072% |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. (Physical properties - After Accelerated Aging) | Tensile strength $\ge$ 14MPa, Ultimate Elongation $\ge$ 400% | Tensile strength 15.2-17.8 MPa, Ultimate Elongation 525.947% - 548.352% |
2. Sample Size Used for the Test Set and Data Provenance:
- Skin Sensitization, Skin Irritation, and Cytotoxicity Tests: The number of biological samples (animals or cells) used is not explicitly stated, but the results refer to "All animals" and "L-929 cells." The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified.
- Residual Powder, Freedom from Holes, Dimensions, and Physical Properties Tests: These tests are performed on the device itself, not human or animal subjects in the same way.
- Freedom from Holes: 125 gloves were tested.
- For other physical property tests (e.g., dimensions, tensile strength), the exact number of gloves or samples is not explicitly mentioned, but the results represent the performance of the device samples.
- The provenance of the data (e.g., country of origin of the data, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This document describes non-clinical performance testing for a medical device (examination gloves). The ground truth for these tests is established by adhering to established international and national standards (ISO 10993-10, ISO 10993-5, ASTM D6124, ASTM D5151, ASTM D6319) and their defined methodologies and acceptance criteria. There is no mention of "experts" in the sense of clinical reviewers for diagnostic accuracy, as this is not a diagnostic device. The "ground truth" is the objective measurement against the specified standard.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study involving human interpretation of data requiring adjudication. The tests involve objective measurements and comparisons against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This is a non-clinical performance study for examination gloves, not an AI-assisted diagnostic or interpretative system that would involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone performance study in the context of an algorithm or AI system was not done. This device is an examination glove, and the tests performed are physical and biological material property tests.
7. Type of Ground Truth Used:
The ground truth used for these tests is based on established industry standards and specifications (e.g., ISO 10993-10, ISO 10993-5, ASTM D6124, ASTM D5151, ASTM D6319). These standards define the acceptable range or criteria for various physical and biological properties of the device.
8. Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning/AI model.
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