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Powder Free White Nitrile Examination Gloves, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

This document describes the acceptance criteria and performance of Powder Free White Nitrile Examination Gloves, Non-Sterile.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   The document does not explicitly state the sample sizes used for each test. The tests are based on ASTM standards (D 6319 – 00ae3, D 6124 – 01) and FDA regulations (21 CFR 800.20, FDA 1000 ml Water Leak Test). These are standard test methods and it can be inferred that samples were taken from manufactured batches for testing. The data provenance is not specified beyond indicating compliance with US standards. It is implied to be prospective testing for product qualification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This is not applicable as the acceptance criteria are based on standardized laboratory tests and regulatory requirements, not on expert consensus or interpretation of medical images.

4. Adjudication method for the test set:

   This is not applicable. The tests involve objective measurements against predefined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., AI in radiology), not for physical medical devices like examination gloves.

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

   This is not applicable. This refers to an "algorithm only" performance, which is relevant for AI/software as a medical device, not for the physical examination gloves described.

7. The type of ground truth used:

   The ground truth is based on established scientific and regulatory standards. For example:

   • Dimensions, Physical Properties, Freedom from Pinholes: Objectively measured against the requirements specified in ASTM D 6319 – 00ae3 and FDA 21 CFR 800.20.
   • Powder Free Residue: Objectively measured against the requirements of ASTM D 6124 - 01.
   • Biocompatibility: In-vivo animal tests (Primary Skin Irritation in Rabbits, Dermal Sensitization tests) with predefined pass/fail criteria.

8. The sample size for the training set:

   This is not applicable. There is no mention of a "training set" as this device is a physical product and its performance is evaluated through direct testing against predetermined standards, not through machine learning or AI models that require training data.

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

   This is not applicable, as there is no training set for this type of device.

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