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A 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

NON-STERILE ORANGE COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS AND WITH A PROTEIN LABELING CLAIM (<200uG/G)

Here's a summary of the acceptance criteria and the study details for the Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves, based on the provided document:

Acceptance Criteria and Device Performance

The device, "Non-Sterile Orange Colored Powdered Latex Patient Examination Gloves with & without Orange/Vanilla Scents and with a Protein Labeling Claim (<200ug/g)", was tested against ASTM D-3578-01aE2 requirements for latex examination gloves and FDA allowable levels for residual protein.

Table of Acceptance Criteria and Reported Device Performance

Study Details

This document describes a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device rather than a comprehensive de novo study to prove the device meets acceptance criteria from scratch as one might for a novel AI device. The tests performed are standard quality control and performance verification tests for medical gloves.

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

   • Physical Properties: For each of the unaged and aged tests, the sample sizes are implicitly shown across four glove sizes (X-Small, Small, Medium, Large) from "LOT # 0226". Specific N for each test per size is not explicitly stated but typically involves multiple samples to derive mean values. The provenance is internal testing by SGMP Company, LTD.
   • Water Tight Test: 125 samples per batch number/size, for both unaged and aged samples across four sizes (X-Small, Small, Medium, Large). The provenance is internal testing by SGMP Company, LTD.
   • Residual Protein Level: A range (98-112 µg/g) and mean (101 µg/g) are reported, suggesting multiple samples were tested. The specific sample size is not stated. The provenance is internal testing by SGMP Company, LTD.
   • All data appears to be retrospective testing of manufactured batches. The country of origin of the data is not explicitly stated but is implicitly SGMP Company, LTD.'s manufacturing location (which is not in the US, but the submission is for US market approval).

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

   • For physical properties, watertight tests, and residual protein analysis, the "ground truth" (acceptance criteria) is established by ASTM D-3578-01aE2 standards and FDA allowable levels. These are established industry and regulatory benchmarks rather than expert consensus on individual cases. No "experts" in the sense of clinicians or radiologists are typically involved in establishing ground truth for these device performance tests; rather, it relies on standardized testing methodologies and interpretations.

3. Adjudication method for the test set:

   • Not applicable. The tests involve objective measurements against predefined standards (ASTM and FDA regulations), not subjective interpretations requiring adjudication.

4. 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 document is for a medical device (latex examination gloves) and does not involve AI or human readers for diagnostic interpretation.

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

   • Not applicable. This is for a physical medical device, not a software algorithm.

6. The type of ground truth used:

   • The ground truth for these tests is established industry standards (ASTM) and regulatory requirements (FDA allowable levels for protein). These are objective, quantitative criteria.

7. The sample size for the training set:

   • Not applicable. This is a physical device, and these are performance verification tests, not a machine learning model requiring a training set.

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

   • Not applicable. (See #7).

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