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510(k) Data Aggregation
(85 days)
The Nitrile Examination Gloves,Green/ Blue/ Black Color are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is provided in color Green, Blue or Black. The subject device is nonsterile.
This document pertains to the 510(k) premarket notification for Nitrile Examination Gloves, Green/Blue/Black Color (K211778). The information provided describes the device, its intended use, and a comparison to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and reported device performance are detailed in the "Summary of Non-clinical Testing" section (page 7 onwards) and specifically in the table.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): Blue/Green Color: XS/S: ≥220, M/L/XL: ≥230; Black: S: ≥220, M/L/XL: ≥230. Width (mm): Blue/Green Color: XS:70±10; S:80±10; M:95±10; L:110±10; XL:120±10; Black Color: S:80±10; M:95±10; L:110±10; XL:120±10. Thickness (mm): Finger: ≥0.05, Palm: ≥0.05. | Length: >230 mm (for all sizes, exceeding the minimums). Width: - Green Color: XS:73 |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 (Acceptable Quality Level of 2.5 for freedom from holes). | Green: 0/125 leaks; Blue: 0/125 leaks; Black: 0/125 leaks. Result: Pass for all. |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg. | Green: 0.08 mg; Blue: 0.07 mg; Black: 0.08 mg. Result: Pass for all. |
| ASTM D412 | Physical Properties (Tensile) | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%. After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400%. | Before Aging: - Tensile Strength: Green: 14.5-16.1 MPa, Blue: 15.1-19.6 MPa, Black: 14.1-41.2 MPa. - Ultimate Elongation: Green: 559-953%, Blue: 745-927%, Black: 545-1193%. After Aging: - Tensile Strength: Green: 14.2-15.5 MPa, Blue: 14.5-15.6 MPa, Black: 14.0-21.8 MPa. - Ultimate Elongation: Green: 541-805%, Blue: 662-740%, Black: 533-797%. Result: Pass for all. |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic. | Under conditions of the study, did not show potential toxicity to L-929 cells. Result: Pass. |
| ISO 10993-10 | Irritation | Non-irritating. | Under the conditions of the study, not an irritant. Result: Pass. |
| ISO 10993-10 | Sensitization | Non-sensitizing. | Under conditions of the study, not a sensitizer. Result: Pass. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size for the test set" in the context of an AI/ML algorithm or a typical clinical trial test set. The tests performed are non-clinical performance tests on the physical product.
- For Watertightness (ASTM D5151): The test involved a sample size of 125 units for each color (Green, Blue, Black). The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, likely conducted in China given the submitter's address. This is retrospective data in the sense that it's reported from completed tests.
For other physical tests (dimensions, physical properties), the specific number of units or measurements per unit is not explicitly stated in this summary, but it would align with the requirements of the respective ASTM standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document is a 510(k) submission for medical examination gloves, which are low-risk Class I devices. The studies performed are physical and biocompatibility tests, not studies involving expert interpretation of medical images or patient outcomes.
- Therefore, no experts (e.g., radiologists) were used to establish ground truth in the context of typical AI/ML algorithm validation. The ground truth for these tests is based on objective physical measurements and chemical/biological assays defined by international and national standards (ASTM, ISO).
4. Adjudication Method for the Test Set
As the tests are objective physical and chemical/biological assessments, no adjudication method (like 2+1 or 3+1 for expert interpretations) was necessary or performed. The results are quantitative measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study is typically performed for diagnostic devices (e.g., AI for medical imaging) to assess how AI assistance impacts human reader performance. Examination gloves do not involve human diagnostic interpretation.
6. Standalone (Algorithm Only) Performance
- Not applicable. This document describes a physical medical device (examination gloves), not an algorithm or AI system. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
The ground truth for this device's performance claims is based on objective measurements and laboratory testing against established industry standards:
- Physical Standards: Adherence to ASTM D6319 (dimensions, physical properties), ASTM D5151 (freedom from holes), and ASTM D6124 (powder content).
- Biocompatibility Standards: Adherence to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation, sensitization).
This is a form of "reference standard" based on published, peer-reviewed, and globally recognized test methodologies.
8. Sample Size for the Training Set
- Not applicable. This document describes a physical medical device. There is no AI/ML algorithm involved, and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, the question of its ground truth establishment is irrelevant in this context.
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