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

Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

This 510(k) submission describes the non-clinical testing performed for the Clean Medical Manufacturing Co., Ltd. Powder Free Vinyl Patient Examination Gloves to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information:

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 a single distinct "test set" sample size with specific data provenance for the overall device evaluation. Instead, it refers to various non-clinical tests with their own sampling plans:

• Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0." This is a sampling plan, implying a sample size was drawn based on AQL (Acceptable Quality Limit) principles for manufacturing quality control. Specific sample numbers are not provided.
• Water Fill Test (Pinholes): "Samplings of AQL 2.5, inspection level I." Again, a sampling plan based on AQL, not a fixed sample size.
• Primary Skin Irritation, Skin Sensitization, Residual Powder Tests: No specific sample sizes mentioned for these tests, only that they were "conducted with results showing..." or "conducted to insure...".

Data Provenance: The data appears to be prospective as it involves the manufacturer (Clean Medical Manufacturing Co., Ltd.) performing tests on their own gloves during production and for the 510(k) submission. The country of origin for the manufacturing and presumably the testing is China (Shijiazhuang, Hebei).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This document describes the evaluation of a medical device (patient examination gloves) through non-clinical laboratory testing and adherence to established standards (ASTM, FDA regulations). There is no mention of "experts" being used to establish a "ground truth" in the way one would for diagnostic imaging or clinical assessment. The ground truth is defined by the technical specifications and performance metrics outlined in the standards themselves.

4. Adjudication Method for the Test Set

Not Applicable. As no expert ground truth or subjective assessment is described, there is no adjudication method involved. The tests are objective and defined by measurement against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically performed for diagnostic devices where human readers interpret results (e.g., radiologists reading images) and the AI's impact on their performance is evaluated. This submission is for patient examination gloves, which do not involve human interpretation in this manner.

6. Standalone Performance Study (Algorithm Only)

Yes, in spirit, but not an "algorithm." The testing described is standalone performance of the physical device itself. The "device" (the glove) is tested in isolation against established performance criteria. There is no AI algorithm involved in the function or evaluation of these gloves. The performance data presented in the table (physical properties, pinhole rate, biocompatibility, powder content) reflects the standalone performance of the glove.

7. Type of Ground Truth Used

The ground truth used is primarily based on established industry standards and regulatory requirements. Specifically:

• ASTM D-5250-06e1: For physical and dimensions testing.
• FDA 1000 ml. Water Fill Test: For pinhole detection.
• ASTM D-6124-06: For residual powder testing.
• Biocompatibility testing guidelines: For primary skin irritation and skin sensitization.

These standards define the acceptable criteria for the glove's performance and safety characteristics.

8. Sample Size for the Training Set

Not Applicable. This submission is for physical medical devices (gloves) and does not involve an AI algorithm or machine learning model that would require a "training set." The manufacturing process for gloves is typically validated through quality control measures, not machine learning training.

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

Not Applicable. As there is no training set, there is no ground truth established for one. The "ground truth" relevant to this submission refers to the performance specifications defined by regulatory bodies and consensus standards against which the manufactured gloves are tested to ensure quality and safety.

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A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.

The provided documents describe the performance of "Syntex Healthcare Products Co., Ltd. Powder Free Nitrile Examination Glove, Pink". This is a medical device classified as a Class I, 21 CFR 880.6250, Polymer Patient Examination Glove, 80 LZA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

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

The document does not specify exact sample sizes for each test. However, the tests are non-clinical (laboratory/material characteristic tests) and typically involve statistical sampling based on the specific ASTM or ISO standard requirements for batch testing. The data provenance is implied to be from the manufacturer's testing in support of their 510(k) submission, likely performed in China (country of origin of the manufacturer) and provided to the FDA. The tests are retrospective, meaning they were conducted on already manufactured devices.

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

This information is not applicable as the evaluation of exam gloves against ASTM and ISO standards involves objective laboratory measurements and tests, not subjective interpretation by human experts to establish ground truth. The "ground truth" is the established technical specification defined by the standards themselves.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process of resolving discrepancies among multiple human readers for subjective assessments (e.g., medical image interpretation). For the physical and chemical tests conducted on examination gloves, the results are quantitative or qualitative assessments against defined criteria, not requiring 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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a disposable examination glove, not an AI diagnostic tool.

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

A standalone performance study was not done. This question is also relevant for AI algorithms. The performance of the examination glove is measured by its physical and chemical properties and biocompatibility, not by an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by conformance to recognized industry standards (ASTM D 6319-00a (2005)e1, ASTM D6124-06, ISO 10993 Part 10, 16CFR 1500.41, 16CFR 1500.3). These standards define the acceptable range or limits for dimensions, strength, freedom from holes, residual powder, and biological response (skin irritation/sensitization).

8. The sample size for the training set

This information is not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

This information is not applicable for the same reason as in point 8.

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