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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.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

The provided text is for a 510(k) summary for Disposable Powder Free Vinyl Exam Gloves. This type of device does not typically undergo studies with the kind of acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone performance assessments that are relevant to AI/ML medical devices or complex diagnostic tools.

The "studies" described in this document are primarily non-clinical tests to ensure the physical properties and safety of the gloves meet established standards for medical devices.

Therefore, many of the requested categories (2-6, 8-9) are not applicable to this submission as they pertain to clinical or diagnostic performance, which is not evaluated for examination gloves in this manner.

Here's an interpretation based on the available information:

Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of samples is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) for the given batch size. Provenance is not specified, but the testing was done for the manufacturer (Xuzhou Full Sun Medical Products Ltd.) in China. This is retrospective testing of manufactured batches.
• Watertight Test: AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated. Provenance is not specified, but the testing was done for the manufacturer. This is retrospective testing.
• Primary Skin Irritation and Skin Sensitization: Sample sizes for these biocompatibility tests are not disclosed but would follow standard biological test protocols. Provenance or specific subjects are not mentioned.

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

N/A. For physical and biocompatibility testing of medical gloves, ground truth is established by standardized test methods and laboratory analysis, not by human expert consensus or interpretation in the way it is for diagnostic imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. This concept is not applicable to the non-clinical testing of examination gloves. Test results are objective measurements against a standard.

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

N/A. This device is an examination glove; it does not involve AI, human readers, or diagnostic interpretation.

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

N/A. This device is an examination glove; it is not an algorithm and does not have standalone performance in the context of AI.

7. The type of ground truth used

For physical and dimensions testing, watertight testing, and residual powder testing, the "ground truth" is defined by the numerical specifications and limits set by the applicable ASTM and FDA standards (e.g., ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06). For primary skin irritation and skin sensitization, the "ground truth" is established by biocompatibility test guidelines that determine the absence of adverse biological reactions.

8. The sample size for the training set

N/A. This device does not involve a "training set" in the context of machine learning or complex model development. The manufacturing process of gloves is subject to quality control, but not a "training set" in this sense.

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

N/A. See point 8.

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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.

Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powder Free Vinyl Exam Glove, Yellow Color:

This document is a 510(k) summary for a medical device (a disposable glove), not a typical AI/ML medical device submission. Therefore, many of the requested categories (like MRMC study, ground truth for training set, number of experts for ground truth, etc.) are not applicable as they relate to advanced diagnostic or AI-driven devices. The focus here is on demonstrating substantial equivalency to a predicate device through established physical performance and biocompatibility standards.

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

¹ The document states the device "meets these requirements" or "conforms fully" or "meets requirements" without providing specific measured values for dimensions, watertight test, biocompatibility, or pinhole requirements in the summary. It refers to data in Section 7 which is not fully elaborated with raw numbers.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
• FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. (Specific sample size 'n' is not explicitly stated, but derived from AQL and inspection levels).
• Primary Skin Sensitization Test: Not specified.
• Residual Powder Test: Not specified.
• Data Provenance: The manufacturing company is Ever Global Enterprise Corporation, based in Dong Nai Province, Vietnam. The tests were likely conducted on gloves produced at this facility. The document doesn't explicitly state if the testing was prospective (done specifically for this submission) or retrospective (using existing factory QA data), but it's implied to be part of the product's quality assurance and validation for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical product (a glove), not a diagnostic device requiring expert interpretation for ground truth. Performance is measured against established physical and chemical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method.

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

Not applicable. This device is not an AI-driven or diagnostic device.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is defined by adherence to established national and international standards for medical examination gloves, specifically:

• ASTM D5250-00E4 (Standard specification for Vinyl Examination Gloves for Medical Application)
• ASTM D-5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
• ASTM D6124-01 (Standard Test Method for Residual Powder on Medical Gloves)
• FDA's 1000 ml Watertight Test (which cites ASTM D-5151-99)
• Biocompatibility requirements (Primary Skin Sensitization)

These standards define objective measurement criteria rather than requiring subjective human "ground truth" interpretation.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set.

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