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The Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-00 and ASTM D5151-99 requirements.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove:

Summary on Acceptance Criteria and Supporting Studies

This 510(k) submission primarily relies on performance testing against established ASTM standards and comparison to legally marketed predicate devices to demonstrate substantial equivalence. It does not involve a study with human readers or AI, as it is for a medical device (examination glove) where performance is evaluated through material properties and barrier integrity rather than diagnostic interpretation.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The data summaries indicate that the proposed product meets or exceeds acceptable scores for the predicate product in nonclinical tests, and satisfies the requirements for a safe and effective, green, aloe vera, no starch donning powder added with 15 milligrams or less of total particulate with protein content labeling claim (200 micrograms or less) per glove and made from Allotex an enzyme treated natural rubber lates claim medical glove."

Regarding point 2 through 9 of your request, the provided 510(k) does not contain information on these aspects because it is not a study involving diagnostic interpretation or human readers, but rather a submission for a physical medical device (examination glove).

However, I will address what one could infer or state based on the type of submission:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for each test, but standard test methods (ASTM) imply specific sample size requirements. These would involve a statistically significant number of gloves or material samples to ensure representativeness as per the ASTM standards cited (e.g., ASTM D5151-99 for water tightness, ASTM D5712-99 for residual protein).
• Data Provenance: The tests are non-clinical, likely performed in a laboratory setting by the manufacturer (Tillotson Healthcare Corporation) or a contracted testing facility. The document does not specify a country of origin for the data itself beyond the manufacturer's location (Bedford, NH, U.S.A.). It is retrospective in the sense that the tests were completed before the submission date.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. "Ground truth" in this context refers to the defined parameters of the ASTM standards and the test results obtained by validated laboratory methods. There are no "experts" in the sense of clinicians or radiologists establishing ground truth for performance of a glove. The standards themselves are developed by committees of experts in materials science and relevant fields.

4. Adjudication method for the test set:

• Not applicable. Test results are objective measurements against defined performance criteria in the ASTM standards. There is no subjective interpretation requiring adjudication.

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 for an examination glove, not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is for an examination glove, not an algorithm.

7. The type of ground truth used:

• Established physical and chemical properties and performance parameters: The "ground truth" is defined by the requirements of the cited ASTM standards for examination gloves, covering aspects like water tightness, tensile properties, protein content, and particulate matter. Biocompatibility tests (rabbit irritation, guinea pig sensitization) also have defined "pass" criteria.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI algorithm.

9. How the ground truth for the training set was established:

• Not applicable. There is no "training set" or "ground truth" in the context of an algorithm. For the glove's manufacturing, the "ground truth" for quality control would be the manufacturing specifications and raw material standards based on the final product's required performance.

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