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510(k) Data Aggregation
(90 days)
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile patient examination gloves. The subject device is blue color. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Disposable Nitrile Examination Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6319 | ||
| Physical Dimensions Test | ||
| Length(mm) | XS/S: ≥220; M/L/XL: ≥230 | >230 (for all sizes) |
| Width (mm) | XS: 70±10; S: 80±10; M: 95±10; L: 105±10; XL: 115±10 | XS: 77-80; S: 87-88; M: 95-98; L: 106-107; XL: 115-117 |
| Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.11; Palm: 0.07 |
| ASTM D5151 | ||
| Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks |
| ASTM D6124 | ||
| Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.11mg |
| ASTM D412 | ||
| Physical Properties - Before Aging | ||
| Tensile Strength | ≥14MPa | 15.1-26.2 |
| Ultimate Elongation | ≥500% | 503-634 |
| Physical Properties - After Aging | ||
| Tensile Strength | ≥14MPa | 14.6-21.8 |
| Ultimate Elongation | ≥400% | 503-620 |
| ISO 10993-5 | ||
| Cytotoxicity | Non-cytotoxic | Not show potential toxicity to L-929 cells |
| ISO 10993-10 | ||
| Irritation | Non-irritating | Not an irritant |
| Sensitization | Non-sensitizing | Not a sensitizer |
All reported device performances indicate that the device "Pass"ed the respective acceptance criteria.
2. Sample size used for the test set and the data provenance
The document states:
- For Watertightness Test (ASTM D5151): "0/125 leaks" suggests a sample size of 125 gloves were tested for holes.
- For other tests like physical dimensions, thickness, and physical properties (tensile strength, elongation), specific sample sizes are not explicitly stated. However, the standards (ASTM D6319, ASTM D412) typically specify sampling plans.
- Data Provenance: The tests were conducted by the manufacturer, Inner Mongolia Boming Medical Supplies Co., Ltd., which is based in Inner Mongolia, China. The data would therefore be retrospective testing performed on manufactured batches of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a disposable nitrile examination glove, and the testing involved evaluating its physical and biocompatibility characteristics against standardized performance metrics rather than interpretative medical imaging or diagnostic results requiring expert consensus.
4. Adjudication method for the test set
Not applicable. As noted above, the evaluation of the device performance against physical and material standards does not involve adjudication by experts. The results are objective measurements or observations (e.g., absence of leaks, tensile strength values).
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 device is a disposable nitrile examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating AI performance in clinical tasks, which is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The ground truth used for this device's evaluation is defined by established international and national standards for medical gloves:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) - Implied for physical properties like tensile strength and elongation.
- ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
These standards provide the pre-defined, objective criteria (e.g., minimum tensile strength, maximum allowable powder content, AQL for watertightness, non-cytotoxicity, non-irritation, non-sensitization) against which the device's performance is measured.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. This device's performance is evaluated through direct physical and biological testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device. The "ground truth" (acceptance criteria) for evaluating the finished product's performance is established by the referenced consensus standards (ASTM, ISO).
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