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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)

A Powder-Free Vinyl Patient Examination Gloves 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). Our Powder-Free Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. 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.

The provided documentation describes the acceptance criteria and the study conducted for the Shandong Taixiang Medical Products Co., Ltd. Powder-Free Vinyl Patient Examination Gloves, Non-Sterile.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a Class I medical device, and the demonstration of substantial equivalence relies on meeting established industry standards and FDA requirements for patient examination gloves.

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

• Test Set Sample Size: The document mentions "samplings of AQL 2.5." While a specific numerical sample size for each test is not explicitly stated, "AQL 2.5" (Acceptable Quality Level 2.5) refers to a sampling plan for inspection. For example, for the FDA 1000ml Water Fill Test, "Inspection Level I" with AQL 2.5 would dictate the sample size based on the lot size. These are standardized sampling methodologies for quality control in manufacturing.
• Data Provenance: The tests were "conducted" by Shandong Taixiang Medical Products Co., Ltd. and their associated labs. The country of origin of the data is implicitly China, where the company is located. The studies are prospective in the sense that they are conducted on manufactured gloves to ensure they meet specifications.

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

Not applicable in the context of this device. Ground truth for medical gloves is established by adherence to existing material standards (ASTM, FDA) and standardized test methods, not by expert consensus on clinical interpretation or image analysis. The "ground truth" is the objective measurement against these established standards.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against predefined specifications. There is no subjective interpretation or need for adjudication by multiple parties for these types of tests (e.g., measuring powder content, water fill test for pinholes, or chemical irritation tests).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret results, and the AI assists in that interpretation. For examination gloves, the performance is assessed through physical and chemical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is primarily established industry standards and regulatory requirements. This includes:

• ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves)
• ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
• FDA 1000 ml Water Fill Test (for barrier integrity/pinholes)
• Biocompatibility testing guidelines (for primary skin irritation and sensitization)

These standards define the acceptable performance parameters for the device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for this product is related to manufacturing processes to ensure consistent quality.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth" establishment in that context.

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