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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 the patient's body, fluids, waste, or environment.

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

Class I nitrile latex patient examination's glove, 80 LZA, powder free. It meets ASTM Standard D 3578-99 requirement for all properties with the exception of ultimate elongation.

This document describes the acceptance criteria and performance of the DERMAGRIP Powder Free Nitrile Examination Glove, Non Sterile.

1. Table of Acceptance Criteria and Reported Device Performance

Note regarding Ultimate Elongation: The device's ultimate elongation (before aging: 670%; after aging: 583%) did not meet the ASTM D 3578-99 standard (min 700% before aging, min 500% after aging). However, the document states that the gloves "meet ASTM D 3578-99 requirement for all properties with the exception of ultimate elongation" and "The performance test data of device as shown above indicate that these nitrile gloves meet ASTM D'3578-99 Standard Specification for Rubber Examination Gloves with the exception of ultimate elongation." This implies that the FDA still considered the device substantially equivalent despite this specific deviation.

The following information is not available in the provided text:

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 mentions "refer to Attachment 8 of Device Test Report of Compliance" for the performance data, but Attachment 8 is not provided. Therefore, the specific sample sizes for each test are not detailed, nor is the data provenance (country, retrospective/prospective).

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 tests described are physical and chemical property tests of a medical device (examination gloves), not diagnostic interpretations requiring expert consensus.

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

   • This information is not applicable for physical and chemical property testing. The results are typically objectively measured and evaluated against a standard. The watertight test does mention "Single Sampling Plan, G-I, AQL 2.5" and "Multiple Sampling Plan, G-II, AQL 4.0," which are statistical sampling methods, not expert 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

   • This information is not applicable as the device is an examination glove, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation.

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

   • This information is not applicable as 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" for this device is established by the specifications defined in industry standards, specifically ASTM D 3578-99 Standard Specification for Rubber Examination Gloves and FDA's 1000ml Watertight Test. The performance data is objectively measured against these established physical and chemical criteria.

8. The sample size for the training set

   • This information is not applicable as the device is an examination glove, not a machine learning model that requires a training set.

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

   • This information is not applicable for the same reason as above.

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