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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 contammation between patient and examiner.

powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-00ed

The provided text describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed study data for a novel device. Therefore, much of the requested information about study design, sample sizes, and expert adjudication for an AI/algorithm-based device is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:
The document states, "Powder free vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10." This indicates that the device underwent testing according to these established standards to demonstrate compliance.

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

• Sample Size for Test Set: Not explicitly stated. The safety and effectiveness are assessed by demonstrating compliance with referenced ASTM standards and FDA regulations for physical properties and biocompatibility. The specific sample sizes for these tests are not provided in this summary but would be detailed in the full test reports referenced by the standards (e.g., ASTM D5250-06, D6124-01).
• Data Provenance: The nature of these tests (e.g., physical property testing, biocompatibility testing) implies they are prospective tests conducted on manufactured glove samples. The country of origin of the data is not specified beyond the submitter's location in China.

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

• Not applicable. This device is a physical product (gloves), not an AI/algorithm-based diagnostic device that requires expert ground truth for interpretation of medical images or data. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, this involves objective measurements against predefined standards, not interpretation by multiple human experts.

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

• Not applicable. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is a physical medical device, not an algorithm. The performance described is the inherent performance of the product itself against established standards.

7. Type of Ground Truth Used

• The ground truth for this device's performance is based on established industry standards and regulatory requirements.
  • For physical properties and dimensions: ASTM standard D 5250-06.
  • For freedom from pinholes: 21 CFR 800.20.
  • For powder residual: ASTM standard D 6124-01.
  • For biocompatibility (skin irritation and sensitization): ISO10993-10.
    These standards define the methodologies and acceptable limits for various performance metrics.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

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