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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, 21 CFR 880.6250, Vinyl Patient Examination Glove, Powder-free, 80L YZ, conform to all requirements of ASTM Standard D5250-92 and FDA water leak test.

The provided text describes the acceptance criteria and study results for "Vinyl Patient Examination gloves, Powder-free" by SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document does not explicitly state a specific sample size for each performance test (e.g., number of gloves tested for dimensions, tensile strength, or water leak). For the Modified Draize Test, it mentions "human subjects," but no specific number.
• Data Provenance: The document does not specify the country of origin of the data. It mentions the applicant is in Shanghai, China, but this doesn't confirm the test location. The study type appears to be prospective, as the testing was done specifically 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):

• This information is not applicable as the device is a physical medical device (gloves), not an AI/diagnostic device that requires expert ground truth establishment for interpretation. The "ground truth" is based on objective measurements and established standards (ASTM D5250-92 and FDA water leak test). For the Modified Draize Test, the interpretation of irritation and allergic contact dermatitis would be done by qualified medical professionals, but their number and specific qualifications are not detailed.

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

• This information is not applicable for this type of device and testing. Adjudication methods are typically used in studies involving subjective interpretation, like image analysis or clinical endpoint assessment. The tests performed are objective measurements against established standards.

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 information is not applicable. This is a physical medical device (gloves), not an AI or diagnostic tool involving human readers or AI assistance.

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

• This information is not applicable. This is a physical medical device (gloves), not an algorithm or AI system.

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

• The ground truth for the dimensional, physical properties, and water leak tests is based on pre-defined engineering and performance standards (ASTM D5250-92 and FDA 1000 ml water leak test). These are objective, measurable criteria.
• For the Modified Draize Test, the ground truth relates to the absence of clinically significant irritation or allergic contact dermatitis in human subjects, as interpreted by medical professionals.

8. The sample size for the training set:

• This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• This information is not applicable. As it's not an AI model, there is no training set or associated ground truth establishment process.

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