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510(k) Data Aggregation
(141 days)
EONS Nitrile Examination Gloves Powder Free
EONS Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
EONS Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
The document provided describes the acceptance criteria and performance of the EONS Nitrile Examination Gloves Powder Free, a medical device. This is a 510(k) premarket notification for a Class I, reserved medical device (non-powdered patient examination glove, product code LZA).
Here's an analysis based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature Compared | Acceptance Criteria | Reported Device Performance (EONS Nitrile Examination Gloves Powder Free) | Result |
|---|---|---|---|
| Dimensions | |||
| Length (ASTM D6319-19) | Min 230 mm | S: 243.69 mm; M: 243.30 mm; L: 242.84 mm; XL: 242.15 mm | Pass |
| Width (ASTM D6319-19) | S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | S: 83.84 mm; M: 94.15 mm; L: 109.07 mm; XL: 114.53 mm | Pass |
| Thickness (ASTM D3767-03) | Palm min 0.05 mm; Finger min 0.05 mm | S: Palm 0.08 mm, Finger 0.12 mm; M: Palm 0.12 mm, Finger 0.08 mm; L: Palm 0.08 mm, Finger 0.10 mm; XL: Palm 0.09 mm, Finger 0.16 mm | Pass |
| Physical Properties | |||
| Tensile Strength (Before Aging) (ASTM D6319-19, ASTM D412-16) | Min 14 MPa | S: 31.26 MPa; M: 23.61 MPa; L: 20.55 MPa; XL: 19.9 MPa | Pass |
| Tensile Strength (After Aging) (ASTM D6319-19, ASTM D412-16) | Min 14 MPa | S: 23.51 MPa; M: 24.33 MPa; L: 21.6 MPa; XL: 19.9 MPa | Pass |
| Ultimate Elongation (Before Aging) (ASTM D6319-19, ASTM D412-16) | Min 500% | S: 799.76%; M: 885.53%; L: 849.69%; XL: 555.30% | Pass |
| Ultimate Elongation (After Aging) (ASTM D6319-19, ASTM D412-16) | Min 400% | S: 815.61%; M: 738.76%; L: 708%; XL: 444.15% | Pass |
| Detection of Holes (ASTM D6319-19, ASTM D5151-06) | AQL 2.5 | AQL 2.5 (for all sizes S, M, L, XL) | Pass |
| Powder Free Residue (ASTM D6124-06) | ≤2 mg/glove | S: 0.6 mg/glove; M: 0.7 mg/glove; L: 0.4 mg/glove; XL: 0.7 mg/glove | Pass |
| Biocompatibility | |||
| In vitro Cytotoxicity | Acceptable (after additional testing for systemic toxicity concern) | Under the conditions of the study, the device is cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern (Result: Pass) | Pass |
| Skin Sensitization | Not a sensitizer | Under the conditions of the study not a sensitizer | Pass |
| Skin Irritation | Not an irritant | Under the condition of study not an irritant | Pass |
| Acute Systemic Toxicity | No systemic toxicity concern | Under the condition of study, the device extracts do not pose a systemic toxicity concern | Pass |
| Material-Mediated Pyrogenicity | Non-pyrogenic response | Under the conditions of the study, the device demonstrate a non-pyrogenic response. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, barrier properties, or biocompatibility). However, it mentions that the tests were performed "according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual" and specific ASTM and ISO standards. These standards typically specify the sampling plans and test methodologies.
The provenance of the data is not explicitly stated in terms of country of origin for the testing itself, but the manufacturer is EONS GLOVES (Thailand) Co., Ltd. The study type is non-clinical data, focusing on performance and biocompatibility rather than clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable to this type of device and study. The "ground truth" for the performance and biocompatibility tests of medical gloves is established by the specified ASTM and ISO standards and their defined methodologies, not by expert consensus or interpretation of images/data by human experts. The results are quantitative measurements against predefined criteria in the standards.
4. Adjudication Method for the Test Set:
This question is not applicable. The performance testing involves objective measurements and adherence to specific standards. There's no human interpretation or adjudication process in the sense of consensus among experts for diagnostic output.
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. This is a physical medical device (gloves), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This is a physical medical device. It does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" for evaluating the EONS Nitrile Examination Gloves Powder Free is based on:
- Established ASTM Standards: For physical properties and barrier properties (e.g., ASTM D6319-19, ASTM D3767-03, ASTM D412-16, ASTM D5151-06, ASTM D6124-06).
- Established ISO Standards: For biocompatibility tests (e.g., ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017).
- Guidance from Regulatory Bodies: Specifically, the "Guidance for Industry and FDA Staff - Medical Glove Guidance Manual."
These standards define the acceptable ranges and methodologies for testing, which serve as the objective performance criteria.
8. The Sample Size for the Training Set:
This question is not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set." The tests are designed to evaluate the physical and biological characteristics of the manufactured product against established quality standards.
9. How the Ground Truth for the Training Set was Established:
This question is not applicable for the reason stated above.
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