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The Powder Free, 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).
This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Examination gloves with protein content labeling are suitable in situations where healthcare worker or patient allergic sensitivity may be a factor. Powder free gloves are intended for use in situations where powder is not desirable.

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 medical treatment. 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 D3578-95 and ASTM D5151-92 requirements.

Here's a breakdown of the acceptance criteria and study information for the Powder Free, Examination Glove, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., water tightness, protein content) or the clinical tests (rabbit irritation, guinea pig sensitization). It only indicates that these tests were performed and the proposed device "Passes" or meets the specified ASTM standards.

Data provenance is not specified. It's implied that the tests were conducted for the purpose of this 510(k) submission, suggesting prospective testing (for the proposed device) and potentially a mix of internal testing or external lab testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. The tests performed are objective, standardized laboratory tests (e.g., ASTM standards for mechanical properties, animal models for safety) that do not rely on expert consensus for establishing ground truth in the same way a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests described are objective measurements and standardized animal studies, not requiring adjudication of human interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or other complex data. The device in question is an examination glove, and its performance is evaluated through physical and safety testing, not human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done for the device. The reported performance metrics (tensile properties, water tightness, protein content, irritation, sensitization) are inherent characteristics of the glove itself, measured directly without human intervention or interpretation that would constitute a "human-in-the-loop" scenario in a diagnostic context.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is based on:

• Established Industry Standards: ASTM D3578-99, ASTM D5151-92, and ASTM D5712-95. These standards define the acceptable physical and performance characteristics for examination gloves.
• Safety Endpoints from Animal Models: "Passes" results for Rabbit Irritation and Guinea Pig Sensitization, indicating that the device did not cause an unacceptable adverse reaction in these standardized biological tests.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device (examination glove) is not an AI/ML algorithm that requires a "training set" of data. Its performance is evaluated directly through physical and biological testing.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no training set for this type of device.

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