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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06e1.

This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This product is a Class I medical device, which means it has a low-risk profile and generally doesn't require extensive clinical trials or complex AI performance studies. The provided document is about a physical product (gloves), not an AI/ML powered device, so many of the requested categories related to AI/ML studies are not applicable.

Here's the breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the summary for the non-clinical tests. The document states that the gloves "meet requirements per ASTM D5250-06 e1, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-152: AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006." These standards themselves define the sampling and testing methodologies, but the specific sample sizes used by the manufacturer for this particular submission are not detailed.

Data provenance: The testing was conducted by the manufacturer, Shandong Jianhong New Material Company, which is located in China. The data would be prospective for the purpose of demonstrating conformity to standards for this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This is not applicable as the "ground truth" for glove performance is established by objective measurements against predefined scientific and regulatory standards (e.g., physical dimensions, tensile strength, barrier integrity, chemical residue, biocompatibility assays), not expert consensus in the medical imaging or diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. For glove testing, the results are typically quantitative measurements against objective criteria, not subject to adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-powered diagnostic devices where human readers (e.g., radiologists) use the AI to improve their performance. This product is disposable medical gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This concept applies to AI algorithms and is irrelevant for a physical product like examination gloves.

7. The Type of Ground Truth Used

The "ground truth" for the performance of these gloves is based on objective, verifiable measurements against established industry standards and regulatory requirements. This includes:

• Physical measurements (e.g., dimensions)
• Chemical residue analysis (e.g., powder residual)
• Biocompatibility assays (e.g., skin irritation, dermal sensitization)
• Integrity tests (e.g., freedom from pinholes, waterleak test).

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train AI/ML algorithms. This product is a physical device that is manufactured according to specifications and then tested for compliance, not "trained."

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a physical product like examination gloves.

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