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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.

Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250. Vinyl Patient Examination Glove, 80LYZ, Powdered with an absorbable dusting starch powder, USP, Class III. conform to all requirements of ASTM Standard D5250-92 and FDA 1000ml water leak test.

This is a 510(k) summary for Vinyl Patient Examination Gloves, Powdered. It describes the device, its intended use, and compares its performance to the ASTM D5250-92 standard and the FDA 1000ml water leak test.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The document states that the "Applicant devices comply with ASTM Standard D-5250-92 and FDA 1000ml water leak test for pin-holes." It also mentions a "Modified Draize Test" for clinical performance.

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

• Non-Clinical Performance Data (Physical Properties and Water Leak Test): The document does not specify the exact sample sizes used for each of the physical property tests (length, width, thickness, tensile strength, elongation). For the FDA Water Leak Test, it mentions an "Inspection Level of S-4," which is a sampling plan specification, but not the absolute number of gloves tested.
• Clinical Performance Data (Modified Draize Test): The document refers to "human subjects" but does not specify the number of subjects used in the Modified Draize Test.
• Data Provenance: The document is from Everrise Glove Products Co., Ltd. in Tainan Hsien, Taiwan, R.O.C. The data appears to be prospective testing conducted by the manufacturer to demonstrate compliance with standards.

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

This information is not provided in the document. The tests performed are objective measurements against defined standards (ASTM D5250-92 and FDA 1000ml water leak test) and a standardized skin irritation test (Modified Draize Test). These do not typically involve human expert "ground truth" establishment in the way medical imaging or diagnostic algorithms do.

4. Adjudication method for the test set

This is not applicable as the tests performed are objective measurements against established standards, not subjective interpretations 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

This is not applicable as the device is a vinyl patient examination glove, not an AI-assisted diagnostic or imaging system.

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

This is not applicable as the device is a physical product (gloves), not an algorithm.

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

The "ground truth" for the non-clinical performance data is defined by the ASTM Standard D5250-92 specifications and the FDA 1000ml water leak test criteria. For the clinical performance, the "ground truth" is the lack of clinically significant irritation or allergic contact dermatitis as determined by the Modified Draize Test. This is based on direct observation of human physiological reactions rather than expert consensus on subjective data or pathology.

8. The sample size for the training set

This is not applicable. The context is a medical device (gloves) undergoing testing against established standards, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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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.

Classified by FDA 's General and Plastic Surgery Device Panel as Class I, 21CFR 880.6250
Viryl Patient Examination Glove, Power Free, 80LYZ
conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

This document describes the performance of the Vinyl Patient Examination Gloves, Powder Free, manufactured by Everrise Glove Products Co., Ltd.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against ASTM Standard D5250-92 and FDA water leak test requirements.

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

The document does not explicitly state the sample sizes used for the physical property tests (length, width, thickness, tensile strength, ultimate elongation) or the FDA water leak test. The data provenance is Taiwan, R.O.C., where the manufacturer is located. The studies are non-clinical performance studies conducted on the applicant's device. No information on whether they were retrospective or prospective is provided, but standard test methods like ASTM D5250-92 are typically conducted prospectively on a sample set.

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

Not applicable. This device is a physical product (gloves), and performance is assessed against established engineering and safety standards (ASTM D5250-92 and FDA water leak test), which do not involve expert interpretation or ground truth establishment in the way an AI diagnostic algorithm would.

4. Adjudication method for the test set:

Not applicable. Performance is measured against quantitative standards, not through adjudication of expert opinions.

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 is a physical medical device (examination gloves), not an AI-powered diagnostic tool engaging human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" for this device's performance is defined by the objective, measurable criteria specified in ASTM Standard D5250-92 and the FDA 1000ml water leak test. These are engineering and quality control standards.

8. The sample size for the training set:

Not applicable. There is no training set as this is a physical product evaluated against standards, not a machine learning algorithm.

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

Not applicable.

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