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Latex Examination Gloves, Powdered, Non-Sterile 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.

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

This document describes the acceptance criteria and performance of the PT. Mandiri Inti Buana Latex Examination Gloves, Powdered, Non-Sterile.

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 size used for the test set for each of the performance characteristics. The tests likely fall under quality control or material testing conducted by the manufacturer.
• Data provenance: The testing was performed by PT. Mandiri Inti Buana, an Indonesian company. The data is retrospective in the context of this 510(k) submission, as it represents pre-market testing results.

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. The characteristics being tested are objective physical and chemical properties of a medical device (gloves), not diagnostic interpretations requiring expert consensus. The "ground truth" is established by adherence to recognized ASTM and FDA standards.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image reading) where multiple experts might disagree. Here, the tests are objective measurements against defined standards.

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:

• This information is not applicable. The device is a physical medical device (examination gloves), not an AI-powered diagnostic tool, and therefore MRMC studies for AI assistance are not relevant.

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

• This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The ground truth for the device's performance is based on established industry standards and regulatory requirements. Specifically, ASTM International standards (D 3578 - 01a2, D 6124 - 01) and FDA regulations (21 CFR 800.20 for water leak test). For biocompatibility, the ground truth is established by standard biological testing protocols (Primary Skin Irritation in Rabbits and Dermal Sensitization assays) designed to demonstrate safety.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of testing a physical medical device like examination gloves. The manufacturing process is subject to quality control, but not in the same way an AI algorithm is "trained."

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

• This information is not applicable, as there is no training set for this device.

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