(155 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs.
Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim are formulated using Latex and offered powder-free.
The provided text describes the 510(k) summary for a Latex Powder-Free Examination Glove. It details the product, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided input:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No irritation potential | Gloves show no irritation. |
| Guinea Pig Maximization | No sensitization potential | Gloves do not display any potential for irritation (likely implying no sensitization). |
| Tensile Strength | Meet or exceed requirements per ASTM D3578-01ae2 | Gloves meet or exceed requirements per ASTM D3578-01ae2. |
| Barrier Defects | Meet or exceed requirements per 21 CFR§800.20 and ASTM D3578-01ae2 | Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D3578-01ae2. |
| Chemotherapy testing | Pass specified chemotherapy drug permeation testing | Tested for chemotherapy drugs using ASTM F739-99a (implies passing, as per substantial equivalence claim). |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the tests. It only lists the tests performed and their results. The data provenance (e.g., country of origin, retrospective/prospective) is also not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established through objective physical and chemical testing against established standards (ASTM, CFR). It does not involve expert consensus in the way medical imaging or CAD systems would.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessment. The tests described are objective laboratory tests.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools, not for medical examination gloves. The document describes a traditional 510(k) submission based on equivalence to predicate devices and adherence to performance standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is an examination glove, not an algorithm or AI system. The tests performed are standalone in the sense that they are laboratory tests on the glove itself, not involving human interpretation or AI.
7. The type of ground truth used
The ground truth for this device is based on:
- Established engineering and chemical standards: ASTM D3578-01ae2 for physical properties (tensile strength, barrier defects) and ASTM F739-99a for chemotherapy permeation.
- Regulatory requirements: 21 CFR§800.20 for barrier defects.
- Biological safety assessments: Primary skin irritation and Guinea Pig Maximization for irritation and sensitization potential, assessed against accepted toxicological paradigms.
8. The sample size for the training set
This information is not applicable. There is no "training set" for a physical device like an examination glove in the context of an algorithm or AI. The substantial equivalence claim is based on manufacturing processes and performance testing against established standards, not machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.