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510(k) Data Aggregation
(265 days)
JiangSu DongXin Medical Technology Co., Ltd
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text is a 510(k) summary for "Powder Free Nitrile Patient Examination Gloves, Blue Color," a Class I medical device. This document is a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a predicate device already on the market.
It's important to understand that a 510(k) submission for a Class I device like examination gloves does not involve the kind of "AI-driven medical device" performance evaluation that the prompt is asking for (e.g., acceptance criteria for AI model performance, human reader improvement studies, ground truth establishment for complex image analysis).
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to physical and biological performance standards for gloves, not the performance of an AI algorithm. Therefore, I cannot fulfill most of the prompt's requests because they are not applicable to the device described in the document.
Here's how the provided information relates to the prompt, and why most points cannot be answered based on this document:
1. A table of acceptance criteria and the reported device performance
The document provides a "Technological Characteristic Comparison Table" (Section 6.0) that lists various physical and chemical properties of the gloves and compares them to the predicate device. These are the "acceptance criteria" for this type of device.
| Features & Description | Acceptance Criteria (Predicate Device K120970, based on ASTM D6319-10/21 CFR 800.20/ASTM D6124-06) | Reported Device Performance (Subject Device K181106) |
|---|---|---|
| Product name | Powder Free Nitrile Patient Examination Glove, Blue Color | Powder Free Nitrile Patient Examination Gloves, Blue Color |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 |
| Product Code | LZA | LZA |
| Color | Blue | Blue |
| Size | Small/ Medium/ Large/X large | Small/ Medium/ Large/X large |
| Indications for Use | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Device Description & Specs | Meets ASTM D6319-10 | Meets ASTM D6319-10 |
| Dimensions -- Length (ILS-2 AQL4.0) | Meets ASTM D6319-10; ≥230mm min. | 232 mm min for all sizes |
| Dimensions -- Width (ILS-2 AQL4.0) | Meets ASTM D6319-10; Small 70-90 mm, Medium 85-105mm, Large 100-120mm, X large 110-130 mm | Small 76-90 mm, Medium 89-102 mm, Large 108-119mm, X large 115-128 mm |
| Dimensions -- Thickness (ILS-2 AQL4.0) | Meets ASTM D6319-10; Finger 0.05mm min., Palm 0.05mm min. | Finger 0.08 mm min., Palm 0.08 mm min. |
| Physical Properties (Before Aging) | Tensile Strength ≥14MPa, Elongation ≥500% | Tensile Strength: 18-25 MPa, Elongation: 550-600% |
| Physical Properties (After Aging) | Tensile Strength ≥14MPa, Elongation ≥400% | Tensile Strength: 17-22 MPa, Elongation: 450-570% |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D6319-10; Inspection Level I AQL2.5, Accept/Reject criteria of 10/11; Water leakage test: 5 noncompliance allowed. (Predicate) | 1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/11; 2) Water leakage test: 5 noncompliance is allowed. (Subject) |
| Residual Powder | Meets ASTM D6124-06 (Reaffirmation 2011); below 2mg of residual powder | Checked on 5pcs sub-samples (N=5). Mean: 0.1mg/pcs |
| Materials used to fabricate | Nitrile | Nitrile |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Biocompatibility | Non-irritant or non-sensitizer (Predicate) | Non-irritant or non-sensitizer; non-cytotoxicity to L-929 cells (Subject) |
| Labeling | -Powder Free, -Patient Examination Glove, -Single Use Only, -Manufactured For:, -Lot, -Blue color | -Powder Free, -Patient Examination Glove, -Single Use Only, -Manufactured For:, -Lot, -Blue color |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions a specific sample size for "Residual Powder" (5 sub-samples) and implies inspection levels for Length, Width, Thickness, and Pinholes (e.g., ILS-2 AQL 4.0, Inspection Level I AQL 2.5). These refer to standardized statistical sampling plans for quality control in manufacturing, not a clinical "test set" for an algorithm.
- Data Provenance: The tests are "non-clinical tests" conducted to verify the device meets acceptance criteria. The manufacturer is JiangSu DongXin Medical Technology Co., Ltd in China. The "data provenance" would be in-house laboratory testing based on specified ASTM and ISO standards. These are prospective quality control tests for manufacturing, not retrospective/prospective clinical data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established standards, not expert interpretations of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is for assessing inter-reader variability in clinical image interpretation, not for glove testing.
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 physical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is adherence to established international standards (ASTM D6319-10 for examination gloves, ISO 10993 for biocompatibility, etc.) and direct physical/chemical measurements (e.g., tensile strength, elongation, dimensions, residual powder weight, water leakage). It's based on quantitative and qualitative measurements against predefined physical and biological acceptance criteria outlined in consensus standards.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
In summary, the provided document details the regulatory clearance of medical examination gloves, which are tested against physical and biocompatibility standards, not AI performance metrics.
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