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510(k) Data Aggregation
(139 days)
ELAZ Nitrile Powder Free Examination Glove is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
ELAZ Nitrile Powder Free Examination Glove is non-sterile, single use only, disposable, powder free examination glove. The glove is made of Acrylonitrile-butadiene rubber. The glove is designed to meets the specification of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the performance testing for the ELAZ Nitrile Powder Free Examination Glove, a Class I medical device. The information provided is for a traditional 510(k) submission, confirming substantial equivalence to a predicate device.
It's important to note that this is a medical glove, not a software or AI-driven diagnostic device. Therefore, many of the typical acceptance criteria and study designs for AI/software-based medical devices (like MRMC studies, expert ground truth adjudication, training/test set provenance for AI, etc.) are not applicable here. The performance evaluation focuses on physical properties, biocompatibility, and compliance with established ASTM and ISO standards for examination gloves.
Here's a breakdown of the provided information, framed within the context of a medical glove substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance
The full table from the document (page 6-7) is replicated here, summarizing the acceptance criteria and the test results for the ELAZ Nitrile Powder Free Examination Glove.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19: Physical Dimensions Test (mm) | |||
| Length (mm) | S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 | S ≥ 220, M ≥ 230, L ≥ 230, XL ≥ 230 (All Pass) | |
| Width (mm) | S: 80±10, M: 95±10, L: 110±10, XL: 120±10 | S: 87-89, M: 99-101, L: 110-113, XL: 112-115 (All Pass) | |
| Finger Thickness (mm) | ≥ 0.05 | S ≥ 0.16, M ≥ 0.15, L ≥ 0.15, XL ≥ 0.13 (All Pass) | |
| Palm Thickness (mm) | ≥ 0.05 | S ≥ 0.11, M ≥ 0.11, L ≥ 0.11, XL ≥ 0.10 (All Pass) | |
| ASTM D5151-19 | Testing for Freedom from holes | AQL 2.5 | Gloves pass AQL 2.5 |
| ASTM D6124-17 | Determine the powder residue for powder free gloves | < 2 mg/glove | Average 0.43 mg/glove |
| ASTM D412, ASTM D573 | Testing for Physical property characteristics | Before Aging: Tensile strength ≥14 MPa, Ultimate Elongation ≥500% After Aging: Tensile strength ≥14 MPa, Ultimate Elongation ≥400% | Before Aging: Tensile strength ≥21 MPa, Ultimate Elongation ≥502% After Aging: Tensile strength ≥18 MPa, Ultimate Elongation ≥465% (All Pass) |
| ISO 10993-5 | Tests for In vitro cytotoxicity | Under the conditions of the study non-cytotoxic. | Under conditions of the study, it was considered "non-cytotoxic" at 25%, 12.5%, and 6.25% and demonstrate cytotoxicity at the 50% and 100% of the test item extract. (Meets non-cytotoxic criteria at relevant concentrations) |
| ISO 10993-10 | Evaluate the endpoint of irritant for biocompatibility | Under the conditions of the study, not an irritant. | Under the conditions of the study, not an irritant. |
| ISO 10993-10 | Evaluate the endpoint of sensitization for biocompatibility | Under the conditions of the study, not a sensitizer. | Under the conditions of the study, not a sensitizer. |
| ISO 10993-11 | Tests for systemic toxicity | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, the device extracts do not pose a systemic toxicity concern |
Regarding the other questions, which are highly relevant for AI/software medical devices but not for this traditional glove submission:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- For physical and performance tests, sample sizes are typically determined by the specific ASTM standard (e.g., AQL levels for freedom from holes, number of samples for tensile strength). These are standardized industry practices, not "data provenance" in the sense of patient data.
- The biocompatibility tests would involve animal models (for in vivo tests like irritation, sensitization, systemic toxicity) or cell cultures (for in vitro cytotoxicity). The document does not specify the exact sample sizes for each test, but they would follow the requirements of the respective ISO standards. This is not "patient data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for medical gloves is established by objective physical measurements and standardized biological tests according to the protocols defined in ASTM and ISO standards. There are no "experts" establishing ground truth in the sense of clinical image review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This applies to clinical interpretation studies, typically for AI/software devices.
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 relates to AI/software performance in diagnostic tasks and human-in-the-loop studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the performance of an AI algorithm. The device is a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for medical gloves is defined by the validated and universally accepted specifications and test methods outlined in the ASTM and ISO standards (e.g., a hole is detected if water leaks, tensile strength is measured by a machine, biological response is quantified by established cytotoxicity assays). It is not clinical ground truth from patient outcomes or expert consensus.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a physical medical device. Manufacturing processes are continually monitored for quality control, but this isn't machine learning training data.
9. How the ground truth for the training set was established
- Not applicable.
In summary, this document presents a standard premarket notification for a Class I medical glove. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are entirely based on established engineering and biomedical testing standards (ASTM and ISO), not on clinical or AI performance metrics. The device successfully met all specified acceptance criteria derived from these standards, demonstrating its substantial equivalence to legally marketed predicate devices.
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