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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body. fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

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

Here's a summary of the acceptance criteria and study information for the Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, Clear (K123590), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a patient examination glove and its acceptance criteria are based on meeting ASTM Standard D5250-06 and specific FDA requirements for glove integrity and biocompatibility, along with demonstrating substantial equivalence to a predicate device (K992821).

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

• Pinhole Testing: 125 gloves were tested for pinhole results (ASTM D5151-06).
• FDA 1000 ml Water Fill Test: Sample sizes were based on AQL 2.5, Inspection Level I, though the exact number is not explicitly stated.
• Physical and Dimensions Testing: Sample sizes for these tests were based on Inspection Level S-2, AQL 2.5, though the exact number is not explicitly stated.
• Residual Powder: Sample sizes were not explicitly stated but guided by ASTM D6124-06.
• Biocompatibility: Sample sizes for ISO 10993-10 (Primary Skin Irritation and Dermal Sensitization) were not explicitly stated.
• Data Provenance: The document does not explicitly state the country of origin for the data, but the submitter is based in Qingzhou, Shandong, China, suggesting the testing was likely conducted there or overseen by the company. The studies are assumed to be retrospective as they are described as "tests performed" to demonstrate compliance.

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

This type of device (patient examination gloves) does not typically involve "experts" establishing a "ground truth" in the way a diagnostic imaging AI would. The "ground truth" for these tests comes from objective measurements against established international and FDA standards (ASTM, ISO). Therefore, this section is not applicable in the context of this device.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against defined standards, not subjective assessments requiring expert 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

Not applicable. This device is a physical glove, not an AI-powered diagnostic tool, so MRMC studies are not relevant.

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

Not applicable. This device is a physical glove, not an algorithm, so standalone AI performance is not relevant.

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

The "ground truth" for this device's performance relies on objective physical, chemical, and biological measurements compared against:

• Established international consensus standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151-06, ISO 10993-10).
• Regulatory requirements (e.g., FDA 1000 ml Water Fill Test).

8. The sample size for the training set

Not applicable. There is no training set for a physical device like a glove. The product is manufactured and tested according to quality control specifications.

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

Not applicable. There is no training set for this device.

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