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Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves is a non-sterile 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 Yellow Synthetic Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text details the 510(k) summary for the "Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves" (K141224), demonstrating its substantial equivalence to a predicate device. The information below is extracted and organized to address your request, focusing on acceptance criteria and the study proving compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against the ASTM D5250-06 (Reaffirmation 2011) standard, ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reaffirmation 2011), and ISO 10993-10 Third Edition 2010-08-01 for biocompatibility.

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

The document does not specify the exact sample sizes used for the individual tests (e.g., pinhole, tensile strength, residual powder). It only states that the device "meets" the requirements of the standards. The data provenance is implied to be from the manufacturer, Shijiazhuang Jiuyuan Plastic Co., Ltd. for the subject device, and Hebei Leader Plastic Co., Ltd. for the predicate device. The nature of the studies (retrospective or prospective) is not explicitly mentioned but typically for these types of device clearances, the performance data would be generated prospectively during product development and testing. The country of origin of the data is China, as both the submitter and predicate device manufacturer are based in China.

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 patient examination glove, and the "ground truth" for its performance is established by standardized physical and chemical tests, not by expert interpretation of patient data or images. The tests are designed to objectively measure properties like tensile strength, pinholes, and biocompatibility.

4. Adjudication method for the test set

Not applicable. The "ground truth" for this device is based on objective measurements and compliance with established ASTM and ISO standards, not on subjective assessments 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

Not applicable. This device is a physical product (patient examination glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.

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

Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

The ground truth used for this device's acceptance is based on:

• Industry Standards: Compliance with specific physical and chemical property limits defined by ASTM International standards (D5250-06, D5151-06, D6124-06).
• Biocompatibility Standards: Compliance with limits defined by ISO (10993-10).
• Regulatory Requirements: Compliance with regulations like 21 CFR 800.20 for freedom from pinholes.

These standards serve as the objective "ground truth" against which the device's performance is measured.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model requiring a training set.

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

Not applicable. As there is no training set for a physical product, there is no ground truth established for one.

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