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The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

The document describes the acceptance criteria and performance data for "Glovetex Examination Gloves, Powdered Non-Sterile (Protein Content Labeling)".

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document describes a study based on "Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test." and "Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95".

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

• The document does not specify the exact sample size used for the various tests. However, it refers to AQL (Acceptable Quality Level) values for Watertight (AQL 1.5) and Physical Properties (AQL 4.0), which are statistical sampling plans used in quality control. This implies that a sufficient sample size was tested to determine compliance with these AQLs.
• Data Provenance: The manufacturing company is listed as PT. WRP Buana Multicorpora in Medan-Labuhan Km 17, INDONESIA. The raw data would originate from their in-house testing facilities in Indonesia. The testing itself is retrospective, as it's a summary of performance data collected after manufacturing for the purpose of regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• This information is not applicable as the document describes performance testing for medical gloves, which relies on standardized physical and chemical tests rather than expert interpretation of medical images or conditions. The "ground truth" here is the objective measurement against the specified ASTM standards and in-house criteria.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., medical image reading) where multiple experts might disagree. For the physical and chemical testing of gloves, objective measurements are taken against predefined criteria, and thus, no expert adjudication is required.

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 described is an examination glove, which is a physical product, not an AI-assisted diagnostic tool or an imaging device. Therefore, an MRMC study is 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 an examination glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth used for this study is based on objective measurements against established industry standards (ASTM D 3578-99, ASTM D 5712-95) and the manufacturer's in-house specifications. This includes physical properties (e.g., tensile strength, elongation, dimensions), chemical properties (e.g., protein content, powder content, moisture content), and performance characteristics (e.g., watertightness).

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 an examination glove. The performance data presented are results from testing a manufactured product against predefined specifications.

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

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

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