Search Results

Powdered 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0084.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

The document does not specify the exact sample size used for each test. Instead, it states that the device "meets" the requirements of the specified ASTM standards and FDA regulations. These standards typically define the sampling plans and acceptable quality levels (AQLs) for testing.

The data provenance is not explicitly stated in terms of country of origin for the testing itself, but the submitting company is based in China. The study appears to be retrospective in the sense that the results are reported as meeting established standards rather than detailing a specific prospective clinical trial.

3. Number of Experts and their Qualifications for Establishing Ground Truth for the Test Set

This type of device (patient examination gloves) does not typically involve human experts to establish ground truth in the way a diagnostic imaging AI would. The ground truth for these tests is defined by the objective physical and chemical standards themselves (e.g., tensile strength, tear resistance, water leak rates, irritation levels). The "experts" in this context would be the technicians and scientists performing the standardized tests according to the protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations of data, particularly in medical imaging or clinical diagnoses where multiple experts might disagree. For objective physical and chemical tests, the results are typically directly measurable and compared against predefined thresholds in the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a medical device for patient examination, not a diagnostic AI system that assists human readers in interpreting medical data. Therefore, an MRMC comparative effectiveness study is not applicable.

6. Standalone (Algorithm Only) Performance Study

Yes, in a sense. The entire submission focuses on the standalone performance of the gloves against established standards (ASTM D5250-004, ASTM D6124-01, 21 CFR 800.20, and ISO10993-10). These are objective tests of the device itself, without human interpretation in the loop beyond ensuring the tests are conducted correctly.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily objective physical and chemical standards, including:

• ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
• 21 CFR 800.20 for freedom from pinholes (water leak test on pinhole AQL).
• ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization tests).

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a product would involve process validation and quality control measures during manufacturing, not algorithmic training data.

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

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

Ask a specific question about this device