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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

PVC films form a barrier to body fluids and bloodborne Pathogens. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Poly (vinyl chloride) glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The provided text details the 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study description of an AI-powered device. Therefore, much of the requested information regarding AI device studies (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) is not applicable or present in this document.

However, I can extract the acceptance criteria and reported device performance for these medical gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The device's compliance with the acceptance criteria is demonstrated through non-clinical performance tests that support a determination of substantial equivalence. The document explicitly states:

• "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet per requirements per ASTM D5250-06 (Reapproved 2011)、 ASTM CFR 800.20 10993-10: D6124-06(Reapproved 2011), per 21 and ISO 2002/Amd. 1 :2006."
• "The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above."

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

• The document does not specify sample sizes for the tests performed (e.g., number of gloves tested for dimensions, pinholes, etc.).
• Data provenance: Not explicitly stated, but given the submitter's address is in China, it's highly probable the testing was conducted in China or by a contracted lab. The tests are based on recognized international (ISO) and US (ASTM, CFR) standards.

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

• Not applicable. This is a medical glove, not an AI device requiring expert ground truth for interpretation. The "ground truth" here is adherence to specified physical and chemical properties as per standards.

4. Adjudication method for the test set:

• Not applicable. This is a medical glove, not an AI device requiring adjudication of interpretations. Compliance is determined by objective measurements against established standard thresholds.

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 medical glove, not an AI device.

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

• Not applicable. This is a medical glove, not an AI device.

7. The type of ground truth used:

• The "ground truth" for the performance of these medical gloves is based on established industry measurement standards and specifications (e.g., ASTM D5250-06, 21 CFR 800.20, ISO 10993-10:2002). These standards define acceptable ranges for physical properties, chemical residue, and biocompatibility.

8. The sample size for the training set:

• Not applicable. This is a medical glove, not an AI device requiring a training set.

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

• Not applicable. This is a medical glove, not an AI device requiring a training set.

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