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510(k) Data Aggregation
(114 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. This latex glove contains 50 micrograms or less of total water extractable protein per gram. In addition, this glove has been tested for use with chemotherapy drugs.
Powder Free Examination Gloves are formulated using latex and have colorants. These gloves are offered non-sterile.
The provided text describes the safety and effectiveness of POWDER-FREE LATEX EXAMINATION GLOVES WITH COLORANTS (K020818) by Allegiance Healthcare Corporation. This is a medical device, specifically a patient examination glove, and the document outlines its performance characteristics against established standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | (Implied: No irritation potential) | Glove does not display irritation potential. |
| Guinea Pig Maximization (Sensitization) | (Implied: No sensitization potential) | Glove does not display sensitization potential. |
| Ultimate Elongation & Tensile Strength | Meets or exceeds requirements for rubber examination gloves per ASTM D3578-01. | Glove meets or exceeds requirements for rubber examination gloves per ASTM D3578-01. |
| Barrier Defects | Exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5. | Glove exceeds requirements per 21 CFR §800.20 and ASTM D3578-01, AQL=2.5. |
| Powder Level | Meets powder level requirements for “Powder Free” designation per ASTM D 3578-01. | Glove meets powder level requirements for “Powder Free” designation per ASTM D 3578-01. |
| Protein Labeling Claim | Meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram. | Glove meets requirements for protein claim of 50 microgram or less of total water extractable protein per gram of glove using the ASTM Lowry test method (ASTM 5712-99). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. The data provenance is implied to be from internal testing conducted by Allegiance Healthcare Corporation. There is no information provided about the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are laboratory-based performance tests against established standards (e.g., ASTM, FDA regulations), not tests that require expert interpretation of results to establish ground truth in the way clinical diagnostic devices might.
4. Adjudication method for the test set
This information is not applicable as the tests described are objective, laboratory-based physical and chemical property assessments, not subjective human-interpreted data that would require an adjudication process.
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 diagnostic imaging devices or other AI-assisted diagnostic tools. The gloves are a physical medical device, and their performance is evaluated through standardized laboratory tests. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (gloves) and not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the device's performance is established by objective, standardized laboratory test methods and established specifications set by regulatory bodies (e.g., 21 CFR §800.20) and industry standards (e.g., ASTM D3578-01, ASTM 5712-99). These standards define acceptable physical properties, chemical characteristics (like protein levels), and biological safety (skin irritation, sensitization).
8. The sample size for the training set
Not applicable. This device is not an AI system or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there is no ground truth establishment for one.
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