Search Results
Found 1 results
510(k) Data Aggregation
(279 days)
Disposable Powder Free Polyethylene Examination Gloves are powder free and non-sterile disposable devices intended for medical purposes that are worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The Disposable Powder Free Polyethylene Examination Gloves are non-sterile disposable patient examination glove. The gloves are made of translucent (clear), low density polyethylene material and are powder free. The Disposable Powder Free Polyethylene Examination Gloves come in four sizes: Small, Medium, Large, X Large. The Disposable Powder Free Polyethylene Examination Gloves act as a barrier to prevent contamination between patient and examiner. The physical and performance characteristics of the device meets all requirements of ASTM D5250 and ASTM D5151.
This document is a 510(k) Premarket Notification for Disposable Powder Free Polyethylene Examination Gloves, seeking substantial equivalence to a predicate device. As such, the presented information pertains to the performance testing of these physical medical gloves, not an AI/software device. Therefore, many of the requested categories related to AI/software performance (e.g., ground truth, expert adjudication, MRMC studies) are not applicable.
Here's an analysis of the provided text in relation to the prompt:
1. A table of acceptance criteria and the reported device performance:
| Characteristics | Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Dimension | ASTM D 5250-19 | Length ≥ 230mm | Pass, the test results meet the acceptance criteria. |
| Width: Small 85±5mm, Medium 95±5mm, Large 105±5mm, X large 115±5mm | |||
| Thickness: Finger ≥ 0.08mm, Palm ≥ 0.08mm | |||
| Physical Properties | ASTM D 5250-19 | Before Aging: Tensile strength ≥11MPa, Ultimate elongation ≥300% | Pass, the test results meet the acceptance criteria. (Tensile strength > 11MPa, elongated rate > 300%) |
| After Aging: Tensile strength ≥11MPa, Ultimate elongation ≥300% | |||
| Freedom from pinholes | ASTM D5250-19, ASTM D5151-19 | Do not show droplet, stream or other type of water leakage at Inspection Level I AQL2.5 | Pass, no leakage. |
| Powder Residual | ASTM D5250-19, ASTM D6124-06 (Reapproved 2017) | Less than 2.0mg/glove | Pass, the test results meet the acceptance criteria. |
| In vitro cytotoxicity | ISO 10993-5 | The test article should not have potential toxicity to L-929 in the MTT method. | Pass, the test article has no potential toxicity to L-929 in the MTT method. |
| Skin sensitization | ISO 10993-10 | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass, the test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article has no potential skin sensitization on guinea pigs in the extraction method. |
| Skin irritation | ISO 10993-10 | The irritation response category in the rabbit should be negligible. | Pass, the response of the test article extract was categorized as negligible under the test condition. The test article has no potential skin irritation on rabbit in the extraction method. |
2. Sample sizes used for the test set and the data provenance:
- The document does not explicitly state the exact sample sizes (number of gloves) used for each specific test (e.g., how many gloves were tested for pinholes, how many for tensile strength).
- The data provenance is from non-clinical tests performed by a qualified test center on the manufactured gloves. The country of origin of the data is not explicitly stated, but the applicant company is Mastermax Plastic (Huizhou) LTD in China. The tests are "retrospective" in the sense that they were performed on product samples, not a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes performance testing for physical medical gloves, not an AI/software device that requires human expert interpretation or ground truth establishment in the traditional sense for a test set. The "ground truth" here is the physical measurement or biological response according to established international standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are typically relevant for human interpretation or consensus in AI/software performance studies. The testing described involves objective measurements against predefined criteria.
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:
- This question is not applicable. The device is a physical product (examination gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this physical device, the "ground truth" is established by adherence to internationally recognized performance standards and their specified test methodologies. These standards (ASTM International, ISO) define precise measurements and acceptable ranges for physical properties (dimensions, tensile strength, elongation, powder residual, freedom from pinholes) and biocompatibility (cytotoxicity, irritation, sensitization).
8. The sample size for the training set:
- This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The product undergoes manufacturing quality control and subsequent batch testing against established specifications.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1