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510(k) Data Aggregation
(58 days)
The Disposable Medical Nitrile Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Disposable Medical Nitrile Examination Gloves (Model: XYS-001, Size Large) is a patient examination qlove and it is made from nitrile compound. It is a single-use, powder-free and nonsterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
The provided text describes the 510(k) clearance for "Disposable Medical Nitrile Examination Gloves (Model: XYS-001)". This is a Class I medical device (non-powdered patient examination glove), and the submission focuses on demonstrating substantial equivalence to a predicate device.
The "study" described is a series of non-clinical bench tests and biocompatibility tests conducted to meet specific performance standards and criteria. There is no multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance study, or training set information as this is not an AI/software device.
Here's the breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Standard/Test Method | Acceptance Criteria | Reported Device Performance | Conclusion (from document) |
|---|---|---|---|---|
| Freedom from Holes | ASTM D5151 | Any glove that shows a droplet, stream, or other type of water leakage shall be considered to have failed the test. | Did not show a droplet, stream, or other type of water leakage | Pass |
| Physical Dimension Test | ASTM D412, D3767 | L size:Width: 95±10mmLength: 230mm minThickness:Finger 0.05mm minPalm 0.05mm min | L size:Width: 110mmLength: 237mmThickness:Finger 0.142mmPalm 0.082mm | Pass |
| Physical Requirement Test (Before Aging) | ASTM D412, D573 | Tensile Strength: 14 Mpa, min.Elongation: 500% min. | Tensile Strength: 19.1 MpaElongation: 508% | Pass |
| Physical Requirement Test (After Aging) | ASTM D412, D573 | Tensile Strength: 14 Mpa, min.Elongation: 400% min. | Tensile Strength: 25.4 MpaElongation: 517% | Pass |
| Powder Free Gloves | ASTM D6124 | Max. 2.0mg | Average: 0.5mg (for 5 pcs) | Pass |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | If viability is reduced to <70% of the blank, it has a cytotoxic potential. The Viab.% of the 100% extract of the test article is the final result. | Under the condition of the test, the test article was found to be cytotoxic. (Note 3 in document indicated additional testing was performed to determine if systemic toxicity was a concern, which was later addressed.) | - |
| Skin Sensitization | ISO 10993-10:2010 | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. If the response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | Under the condition of the test, the test article was found to be non-sensitizing. | - |
| Intracutaneous Reactivity | ISO 10993-10:2010 | The requirements of the test are met if the final test article score is 1.0 or less. | The result showed that the polar and non-polar extract of the final test sample score is less 1.0. | - |
| Acute Systemic Toxicity | ISO 10993-11:2017 | (1) If during the observation period none of the mice treated with the test article extract exhibited a significantly greater biological reactivity than control mice, the test article met the requirements. If two or more animals died, or if abnormal behavior such as convulsions or prostration occurs in two or more animals, or if body weight loss greater than 10 % occurs in three or more animals, the test article did not meet the requirements. (2) If any animals treated with the sample exhibited only slight signs of biological reactivity, and no more than one animal showed gross symptoms of biological reactivity or died, repeat the testing using groups of ten animals. On the repeat test, if all ten animals treated with the test article extract exhibited no scientifically meaningful biological reactivity above the vehicle control animals during the observation period, the test article met the requirements. | Under the condition of the test, the test article was found to be non-systemic toxicity. | - |
2. Sample Sizes Used for the Test Set and Data Provenance
- Freedom from Holes: 200 samples tested.
- Physical Dimension Test: 13 samples tested/size (only "L" size reported in summary).
- Physical Requirement Test: 13 samples tested/L size.
- Powder Free Gloves: 5 samples.
- Biocompatibility Tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity): The specific sample sizes for animals or cell cultures are mentioned within the "Test method" description (e.g., L-929 cells, guinea pigs for sensitization, rabbits for intracutaneous, mice for systemic toxicity - usually groups of 3-5 for initial tests, or 10 for repeat tests according to the standards).
- Data Provenance: Not explicitly stated (e.g., country of origin for the testing labs), but the submitter's address is in Anhui Province, China. The studies are retrospective in the sense that they were completed tests submitted as evidence of performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical glove, and the "ground truth" is established by standard laboratory testing methodologies and objective measurements against defined standards (ASTM and ISO). There are no human experts "establishing ground truth" in the diagnostic sense for this type of device.
4. Adjudication Method for the Test Set
Not applicable. The tests are benchtop, objective measurements with pre-defined pass/fail criteria from international standards. There is no subjective human assessment requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI devices where human reader performance is being evaluated with and without AI assistance. This device is a physical barrier (glove).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This is not an AI/software device.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on objective measurements against established international standards and specifications (e.g., ASTM D6319-19 for chemical and physical properties, ASTM D5151 for freedom from holes, ASTM D6124 for powder residue, and ISO 10993 series for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/software device.
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