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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.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

Device: Powder Free Vinyl Patient Examination Gloves, Clear (Non-colored)
Manufacturer: CHANGDA PLASTIC PRODUCT CO., LTD
510(k) Number: K103196

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 sample size used for the testing of the gloves. It refers to established ASTM and CFR standards, implying that the testing was conducted in accordance with the sampling requirements specified within those standards.

The data provenance is not directly stated in terms of country of origin or whether it was retrospective/prospective. Given this is a 510(k) submission for a physical product (gloves), the testing would have been prospective, involving the manufacturing and subsequent testing of sample gloves. The manufacturer is CHANGDA PLASTIC PRODUCT CO., LTD, located in China, so it is highly probable the testing was conducted in China.

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

This information is not applicable to this type of device and submission. The ground truth for glove performance is established by adherence to physical and biological testing standards (ASTM, CFR, ISO) rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be technicians/scientists conducting the standardized tests.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation (e.g., medical imaging). For the physical and biological testing of gloves, there is no adjudication method of this type. The results are objective measurements against defined pass/fail criteria in the standards.

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

No, a MRMC comparative effectiveness study was not done. MRMC studies are relevant for AI-assisted diagnostic devices or imaging interpretation systems, not for a physical product like patient examination gloves.

6. If a Standalone Performance Study Was Done

Yes, a standalone performance study was done. The entire set of tests outlined in the "Device performance" column against the "Acceptance Criteria (Standard)" constitutes a standalone performance study. The tests evaluate the performance of the gloves themselves (their dimensions, physical properties, pinhole integrity, powder residue, and biocompatibility) against established standards, without human interaction beyond the conduct of the tests.

7. The Type of Ground Truth Used

The ground truth used is based on established industry and regulatory standards:

• ASTM standard D 5250-06: For dimension, physical properties, and powder residual.
• 21 CFR 800.20: For freedom from pinholes (water leak test AQL).
• ASTM D6124-06: For powder residual.
• ISO10993-10: For biocompatibility (Primary Skin Irritation and Dermal sensitization).

These standards define the acceptable range or threshold for each characteristic, and the testing measures whether the device meets these pre-defined, objective criteria.

8. The Sample Size for the Training Set

This concept is not applicable to this medical device. "Training set" refers to data used to train machine learning algorithms. Patient examination gloves are physical products, not AI/ML devices, and therefore do not have a training set in that context.

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

As noted in point 8, the concept of a "training set" for this device is not applicable.

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