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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.

Acceptance Criteria and Study for Powder Free Vinyl Patient Examination Gloves

This device is a Class I medical device and does not require a complex clinical study for approval. The submission relies on non-clinical testing and adherence to established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, or number of animals for biocompatibility). However, the tests are conducted in accordance with the referenced ASTM and ISO standards, which would define appropriate sample sizes for these types of assessments.

• Data Provenance: The device manufacturer is SHIJIAZHUANG BENESTAR PLASTIC CO., LTD. located in CHINA. The testing was conducted to meet international standards (ASTM and ISO) and US regulations (21 CFR).

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

• Ground Truth Establishment: For this type of device and testing, "ground truth" is established by adherence to standardized testing protocols and objective measurements outlined in the referenced ASTM standards, 21 CFR, and ISO standard. There is no mention of human experts establishing ground truth for the test set beyond the qualified personnel performing the standardized laboratory tests.
• Qualifications of Experts: The document does not specify the qualifications of the individuals who performed the tests. It is assumed that these tests were conducted by trained technicians in laboratories accredited to perform such work in accordance with the respective standards.

4. Adjudication Method for the Test Set

Not applicable. The performance is assessed against objective, measurable criteria defined by the referenced standards, not through human adjudication of subjective data. (e.g. 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging software) where human interpretation is a key component. This device is a patient examination glove, and its effectiveness is determined by its physical properties and biocompatibility, not by human interpretation of its function.

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

This concept is not applicable to the device. "Standalone" performance usually refers to the performance of an AI algorithm without human involvement in interpretation or decision-making. Since this device is a physical glove, not an algorithm, this question is not relevant. The device itself is "standalone" in its function as a barrier.

7. The Type of Ground Truth Used

The ground truth used for this device is based on objective measurements against established national and international standards. This includes:

• Physical measurements (e.g., dimensions)
• Mechanical property tests (e.g., tensile strength, elongation)
• Chemical residue analysis (powder residual)
• Barrier integrity tests (freedom from pinholes based on water leak AQL as per 21 CFR 800.20)
• Biocompatibility assessments based on animal models (primary skin irritation and dermal sensitization) as defined by ISO10993-10.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical and biological properties.

9. 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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