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510(k) Data Aggregation
(151 days)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.
The provided text describes the acceptance criteria and the results of a study for the "Iconic Nitrile Glove," a non-powdered patient examination glove.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics/Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Average Results) | Final Status |
|---|---|---|---|---|
| Freedom from hole - ASTM D5151-19 | Freedom from hole | AQL 2.5 | Non sterile (for all sizes: Small, Medium, Large, X-Large) | Pass |
| Dimensions | Overall Length (mm) | Min 230mm | Small: 234.9, Medium: 246, Large: 236.5, X-Large: 241.0 | Pass |
| Dimensions | Width (±10mm) | Small - 80, Medium- 95, Large-110, X-large-120 | Small: 84.7, Medium: 97.4, Large: 106.4, X-Large: 114.6 | Pass |
| Dimensions | Thickness at Palm | Min: 0.05 mm | Small: 0.10, Medium: 0.06, Large: 0.08, X-Large: 0.09 | Pass |
| Dimensions | Thickness at Fingertip | Min: 0.05 mm | Small: 0.12, Medium: 0.10, Large: 0.13, X-Large: 0.13 | Pass |
| ASTM D6319-19 (Before Aging) | Physical properties before aging - Tensile Strength | 14 MPa, min. | Small: 21.2, Medium: 25, Large: 18.9, X-Large: 18.4 | Pass |
| ASTM D6319-19 (Before Aging) | Physical properties before aging - Ultimate Elongation | 500 % min | Small: 896.3, Medium: 893.8, Large: 919.7, X-Large: 930.9 | Pass |
| ASTM D6319-19 (After Accelerated Aging) | Physical properties after accelerated aging - Tensile Strength | 14 MPa, min. | Small: 23.5, Medium: 26.8, Large: 22.2, X-Large: 19.3 | Pass |
| ASTM D6319-19 (After Accelerated Aging) | Physical properties after accelerated aging - Ultimate Elongation | 400 % min | Small: 879.2, Medium: 787.9, Large: 855.3, X-Large: 858.6 | Pass |
| Powder-free Residue - ASTM D6124-06 | Powder-free Residue | < 2.0 mg per glove | Small: 0.78, Medium: 0.24, Large: 0.38, X-Large: 0.54 | Pass |
| ISO 10993-5 | Test for Invitro cytotoxicity | Cytotoxic Characteristics (Pass) | Pass | Pass |
| ISO 10993-10 | Test for irritation and Skin Sensitization | Non - Skin Sensitized (Pass) | Pass | Pass |
| ISO 10993-11 | Tests for systemic toxicity | Not induce systemic toxicity (Pass) | Pass | Pass |
| ISO 10993-23 | Tests for irritation | Non-Irritant (Pass) | Pass | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each test (e.g., how many gloves were tested for pinholes, or how many samples for biocompatibility). However, it refers to standard methodologies like ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, and ISO 10993 series, which inherently define sample sizes for achieving statistical significance. The data provenance is not specified beyond the fact that the tests were conducted for "Iconic Medicare Sdn Bhd" located in Malaysia. It is a non-clinical, laboratory-based testing scenario.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For this type of device (nitrile gloves), the ground truth is established through adherence to standardized international test methods (ASTM and ISO standards) and their specific acceptance criteria, rather than expert consensus on subjective observations.
4. Adjudication method for the test set
Not applicable. As the ground truth is based on quantitative measurements and adherence to specified standard criteria, no human adjudication method (like 2+1 or 3+1) is mentioned or implied.
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 nitrile glove, not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a nitrile glove, not an algorithm.
7. The type of ground truth used
The ground truth is established by adherence to internationally recognized standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23) which define specific physical, mechanical, and biological properties and their acceptance limits.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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