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510(k) Data Aggregation
(58 days)
The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
The document provided is a 510(k) summary for Disposable Nitrile Powder-Free Examination Gloves. It details the safety and effectiveness information, comparing the proposed device to a legally marketed predicate device. The information provided heavily focuses on non-clinical performance testing rather than studies involving human readers or AI.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
| No. | Name of the Test Methodology / Standard | Acceptance Criteria | Results |
|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization) | Skin Sensitization Test: provided grades less than 1, otherwise sensitization. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. |
| 2 | ISO 10993-10:2010 (Skin Irritation) | Skin Irritation Test: If the primary irritation index is 0-0.4, the response category is Negligible. 0.5-1.9 means slight, 2-4.9 means moderate, 5-8 means severe. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | The viab.% of the 100% extract of the test article is the final result, and if viability is reduced to <70% of the blank, it has cytotoxic potential. | Viab.% of 100% test article extract is 17.1%. (This means the proposed device has potential toxicity to L-929 in the MTT method, but Analysis 3 clarifies this is mitigated by systemic toxicity tests). |
| 4 | ISO 10993-11: 2017 (Systemic Toxicity) | Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. | There was no evidence of systemic toxicity from the extract. |
| 5 | ASTM D6124-06 (Residual Powder) | powder residue limit of 2.0 mg | 0.15-0.19 mg /glove |
| 6 | ASTM D5151-06 (Holes in Medical Gloves) | Samples number: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤7 gloves for water leakage | no glove water leakage found |
| 7 | ASTM D6319-10 (Nitrile Examination Gloves) | Dimensions: S: width 80±10mm, Length ≥ 220 mm; M: width 95±10mm, Length ≥ 230 mm; L: width 110±10mm, Length ≥ 230 mm; XL: width 120±10mm, Length ≥ 230 mm. Thickness: Finger ≥ 0.05 mm, Palm ≥ 0.05 mm. Physical properties: Before aging: Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 500%; After Accelerated Aging: Tensile strength ≥ 14MPa, Ultimate Elongation ≥ 400%. | Dimensions (Lot no.:210515): S: width: 85-87 mm, Length 247-253 mm; M: width 88-96 mm, Length 242-257 mm; L: width 90-99 mm, Length 240-254 mm; XL: width 110-115 mm, Length 245-253 mm. Thickness (Lot no.:210515): Finger 0.09-0.21 mm, Palm 0.06-0.15 mm. Physical properties (Lot no.:210515): Before aging: Tensile strength 14.1-22.5 MPa, Ultimate Elongation 503.274% - 670.613%; After Accelerated Aging: Tensile strength 14.6-20.8 MPa, Ultimate Elongation 411.403% - 592.683%. (Similar results reported for other lots 210518, 210520) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set:
- For the hole detection test (ASTM D5151-06), the sample size specified in the acceptance criteria is 125 gloves. The actual results state that "no glove water leakage found," implying 125 gloves were tested.
- For biocompatibility tests (ISO 10993 series), the specific number of animals or samples is not explicitly stated in the summary, but standard protocols for these tests involve specific sample sizes (e.g., animal groups for irritation/sensitization, cell cultures for cytotoxicity).
- For material properties (tensile strength, elongation, dimensions), the results are provided for specific "Lot no." (e.g., 210515, 210518, 210520), suggesting samples were taken from these production lots. The exact sample size per lot for these physical tests is not detailed in the summary.
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being Shandong Maida Medical Technology Co.,Ltd. in China. The studies are non-clinical performance tests, meaning they are not conducted on human subjects and therefore the concepts of "retrospective or prospective" as typically applied to clinical studies are not directly applicable. These are laboratory/bench tests to confirm product specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a new medical device submission for examination gloves, which is a Class I device. The "ground truth" for this type of device is established through adherence to recognized international and national standards (ISO, ASTM) for material properties, biocompatibility, and physical characteristics. There is no mention of "experts" in the context of human data interpretation or labeling for AI models. The "ground truth" here is the pass/fail criteria defined by these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or AI where adjudication of conflicting opinions would be necessary. The tests are based on objective measurements and established standard protocols.
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 submission is for medical examination gloves, which are physical devices, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
The ground truth for this device's performance is based on accepted international and national standards (e.g., ISO 10993 series for biocompatibility, ASTM D6124 for residual powder, ASTM D5151 for holes, ASTM D6319 for physical properties). The device's performance is compared against the specific numerical and qualitative criteria defined within these standards.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for a physical medical device like an examination glove. These are non-clinical performance tests to ensure the product meets manufacturing and safety specifications.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
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