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Powder free vinyl 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.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and study information for the K101663 device, structured as requested:

Acceptance Criteria and Device Performance

Study Information

This submission is for a Class I medical device (Patient Examination Glove) and relies on non-clinical testing for substantial equivalence. Clinical trials are typically not required for such devices.

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

   • The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for pinholes, number of rabbits/guinea pigs for biocompatibility). It generally states that the device "meets requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." These standards inherently define the sample sizes and testing methodologies required.
   • Data Provenance: The tests are performed according to international and US standards (ASTM, 21 CFR, ISO). The manufacturer is based in China. The specific location where the testing was conducted is not explicitly stated, but it would have been conducted by a qualified testing laboratory. The data is retrospective in the sense that the tests were completed before the 510(k) submission.

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

   • For this type of device, "ground truth" is established by adherence to standardized testing protocols. The "experts" are the trained technicians and scientists performing the tests in certified laboratories, who are qualified to execute the specific ASTM, CFR, and ISO standards (e.g., performing physical property tests, waterleak tests for pinholes, and conducting biocompatibility studies). The document does not specify the number or detailed qualifications of these individuals but implies they are competent to conduct tests according to the cited standards.

3. Adjudication method for the test set:

   • Not applicable in the conventional sense for this type of non-clinical testing. The "adjudication" is inherent in whether the test results comply with the specified pass/fail criteria outlined in the standards (ASTM, 21 CFR, ISO). There is no "consensus" among multiple readers/experts in interpreting results for patient examination gloves; rather, there is a direct measurement against defined thresholds.

4. 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:

   • No MRMC comparative effectiveness study was done. This type of study is irrelevant for a patient examination glove, which is a physical barrier device, not an interpretative diagnostic or assistive AI tool.

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

   • Not applicable. There is no algorithm or AI component in this device. Performance is measured against physical and chemical properties.

6. The type of ground truth used:

   • Standards-based measurement: The "ground truth" is defined by the objective pass/fail criteria established within the referenced national and international standards (ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, and ISO10993-10). For example, for "Freedom from pinholes," the ground truth is simply whether the glove passes the waterleak test according to 21 CFR 800.20's AQL (Acceptable Quality Level). For biocompatibility, the ground truth is the biological response (e.g., no primary skin irritation, no dermal sensitization) as assessed by standard animal models per ISO10993-10.

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI, so there is no "training set." The product is manufactured and then tested against established quality control standards.

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

   • Not applicable, as there is no training set for this device.

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