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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Powder free vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06

This document describes the Xuzhou Full Sun Medical Products Ltd.'s Disposable Powder Free Vinyl Synthetic Examination Glove. This device is a non-sterile, disposable examination glove made of Poly Vinyl Chloride, available in sizes XS, S, M, L, XL. It is intended for medical purposes to prevent contamination between patients and examiners. The device's performance was compared to a predicate device (K963751) and determined to be substantially equivalent based on various tests.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Property, Pinhole, Residue Powder, Skin Irritation, Dermal Sensitization). It only mentions that "Tests were conducted following the recommended procedures outlined in the respective consensus."

The data provenance is from China, as the manufacturer is "Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu 221316 China". The data appears to be prospective as it refers to tests conducted on "Our Device" to demonstrate its performance against established standards.

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

This type of information is not applicable to this submission. The tests are for physical and biological properties of a medical glove, not for diagnostic accuracy that would require expert-established ground truth. The "ground truth" here is the adherence to established industry standards (ASTM, ISO, CFR) which are objective measurements.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. For objective tests on a physical device like an examination glove, adjudication is not applicable as the results are based on standardized laboratory procedures and measurements.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI algorithms or diagnostic devices where human readers interpret medical data. The device in question is a physical medical glove.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

A standalone study, generally referring to the performance of an algorithm without human intervention, is not applicable to this device. The device is an examination glove, not an AI algorithm or a diagnostic tool that involves such a performance assessment.

7. The Type of Ground Truth Used

The "ground truth" used in this context is the adherence to established industry standards and regulations. These include:

• ASTM D5250-06 (Standard Specification for Vinyl Examination Gloves)
• ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
• 21 CFR 800.20 (Puncture Resistance for Medical Gloves)
• ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
• ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)

These standards define the acceptable range or threshold for each performance characteristic.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical glove and does not involve an "algorithm" or "training set" in the context of AI or machine learning. The term "training set" is typically used for developing AI models.

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

Not applicable. As the device is not an AI algorithm, there is no "training set" or a ground truth established for one. The performance evaluation is based on direct measurement against predefined regulatory and industry standards.

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