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Powder Free Latex Examination Gloves, Non Sterile (contains 50 micrograms/dm² or less of total water extractable protein) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Non Sterile (contains The 50 micrograms/dm² or less of total water extractable protein) is Class I Device. These gloves are made of natural rubber latex. The gloves can be used either right or left hand (ambidextrous), Disposable, Single Use and Non Sterile. The Specification of this device meets the requirements of ASTM Standard D 3578 - 05 and FDA 1000ml Water Leak Test.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (for test set/performance data)

The document does not explicitly state the sample sizes used for each specific test. However, it implies that tests were conducted on the "Powder Free Latex Examination Gloves" to ensure they meet the defined standards.

• Data Provenance: The document does not specify the country of origin for the data itself, but the manufacturer is PT. INTAN HEVEA INDUSTRY, located in Indonesia. The studies appear to be retrospective in the sense that they are reporting on tests conducted on already produced gloves to demonstrate compliance with established standards.

3. Number of Experts and Qualifications (for establishing ground truth)

• This information is not applicable to this type of device and study. The "ground truth" here is objective measurement against established ASTM and FDA standards for physical, chemical, and biological properties, not expert interpretation of medical images or clinical outcomes.

4. Adjudication Method (for test set)

• This information is not applicable. The tests are objective measurements against defined criteria, not subjective assessments requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy or efficiency. This document describes an examination glove, which is not a diagnostic device.

6. Standalone Performance Study

• Yes, in a broad sense, a standalone performance assessment was done. The document outlines a series of non-clinical tests conducted on the examination gloves themselves to demonstrate their inherent physical, chemical, and biological properties without human intervention or interpretation (beyond conducting the tests). The "Performance" column in the table effectively reports the standalone performance of the device against predefined standards.

7. Type of Ground Truth Used

• The ground truth used is based on objective measurements and adherence to established industry and regulatory standards. These standards define acceptable ranges or outcomes for physical properties (dimensions, physical strength), chemical properties (powder residue, protein content), and biological properties (biocompatibility). For example, a glove "Meets" the freedom from pinholes test if it passes the FDA 21 CFR 800.20 methodology.

8. Sample Size for the Training Set

• This information is not applicable. This device is a physical product (examination glove), not an AI/ML algorithm that requires a training set.

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

• This information is not applicable since there is no training set for this type of device.

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