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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

The device being discussed is "Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet)". The study conducted to prove the device meets acceptance criteria is based on the performance data of the gloves according to ASTM D6319-00a3 standards and the FDA 1000 ml watertight test, as well as biocompatibility tests.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

• Indicates average results from Attachment B2, which is not provided in the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test in the provided performance data. However, for the "Watertight (1000 ml)" test, an AQL (Acceptable Quality Level) of 2.5% is mentioned, which implies a sampling plan was used according to ASTM D6319-00a3.

The data provenance is from Malaysia, where Seal Polymer Industries SDN. BHD. is located. It is
prospective testing conducted by the manufacturer to demonstrate compliance with standards.

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 is not applicable as the device is a medical glove, and the "ground truth" is established by adherence to physical and chemical standards and biocompatibility tests, not subjective expert evaluation of medical images or conditions. The standards themselves (ASTM D6319-00a3 and FDA requirements) define the objective criteria.

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

Not applicable. The tests are objective measurements based on established standards, not subjective interpretations 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 not an AI-enabled diagnostic device.

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

Not applicable. This is not an AI-enabled diagnostic device. The performance data presented refers to the physical and chemical properties of the glove itself.

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

The "ground truth" for this device is based on established industry standards and regulatory requirements:

• ASTM D6319-00a3 Standard: Defines the physical properties and performance requirements for nitrile examination gloves.
• FDA 1000 ml watertight test: A specific regulatory requirement for barrier integrity.
• FDA minimum powder residual content: A specific regulatory limit for powder on gloves.
• Biocompatibility test results: Objective laboratory tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the material's interaction with biological systems.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training paradigm.

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

Not applicable, as no training set is relevant for this device.

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