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510(k) Data Aggregation
(104 days)
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This document describes the premarket notification for the "Disposable Nitrile Medical Examination Glove". The acceptance criteria and the study proving the device meets these criteria are detailed through a series of tables and text.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | Pass for all sizes | ||
| Length (mm) | ≥ 230 | XS, S, M, L, XL: > 230 | |
| Width (mm) | XS: 75 ± 5S: 85 ± 5M: 95 ± 5L: 105 ± 5XL: 115 ± 5 | XS: 77-79S: 82-86M: 95-97L: 104-106XL: 115-117 | |
| Thickness (mm) - Finger | ≥ 0.05 | XS: 0.10-0.12S: 0.09-0.12M: 0.08-0.12L: 0.09-0.13XL: 0.11-0.12 | |
| Thickness (mm) - Palm | ≥ 0.05 | XS: 0.06-0.10S: 0.07-0.09M: 0.06-0.09L: 0.06-0.09XL: 0.06-0.08 | |
| ASTM D5151 - Watertightness Test for Detection of Holes | Freedom from Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaksS: 1/125 leaksM: 0/125 leaks (Implied Pass based on AQL 2.5) |
| ASTM D6124 - Powder Content | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | XS: 0.01 mg/gloveS: 0.02 mg/gloveM: 0.03 mg/gloveL: 0.01 mg/gloveXL: 0.02 mg/glove (Pass) |
| ASTM D412 - Physical Properties (Before Aging) | Tensile Strength | ≥ 14 MPa | XS: 15.3-16.3S: 15.6-19.2M: 15.9-17.3L: 15.3-17.2XL: 15.3-17.1 (Pass) |
| Ultimate Elongation | ≥ 500% | XS: 525-579S: 518-571M: 515-575L: 521-562XL: 523-568 (Pass) | |
| ASTM D412 - Physical Properties (After Aging) | Tensile Strength | ≥ 14 MPa | (Results not explicitly listed but labeled "Pass") |
| Ultimate Elongation | ≥ 400% | (Results not explicitly listed but labeled "Pass") | |
| ISO 10993-5 - Cytotoxicity | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is not cytotoxic to L-929 cells (Pass) |
| ISO 10993-10 - Irritation | Irritation | Non-irritating | Under the conditions of the study, not an irritant (Pass) |
| ISO 10993-10 - Sensitization | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer (Pass) |
2. Sample size used for the test set and the data provenance
- ASTM D5151 (Watertightness): For sizes XS, S, and M, 125 gloves were tested for each size (e.g., XS: 0/125 leaks, S: 1/125 leaks, M: 0/125 leaks). The sample sizes for L and XL are not explicitly stated, but the test methodology implies a standardized approach across sizes.
- Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): Specific sample sizes for these tests are not explicitly provided in the document.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective, beyond stating that non-clinical tests were conducted to verify the device met all design specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests conducted are non-clinical, laboratory-based tests evaluating the physical and biological properties of the medical examination glove against recognized international and national standards (e.g., ASTM, ISO). Ground truth, in the context of expert consensus, is not relevant for these types of tests.
4. Adjudication method for the test set
Not applicable. The tests are standardized laboratory procedures with objective measurements against predefined acceptance criteria. There is no mention of expert adjudication for interpreting results.
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 is a submission for a medical examination glove, which is a physical device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance evaluation of the Disposable Nitrile Medical Examination Glove is based on widely accepted, published national and international standards for medical gloves. Specifically:
- Physical properties (dimensions, tensile strength, elongation): ASTM D6319 and ASTM D412.
- Freedom from holes: ASTM D5151.
- Powder content: ASTM D6124.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity): ISO 10993-10 and ISO 10993-5.
These standards define the objective and measurable criteria that the device must meet.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set".
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device, there is no training set).
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