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 5250-00ed

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

The document describes a 510(k) premarket notification for "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)." It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). The testing is non-clinical and conducted by the manufacturer, SUQIAN GREEN GLOVE CO.,LTD, located in China. The data would be considered prospective for the purpose of demonstrating equivalence for this submission.

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

This information is not applicable. The evaluations are based on established ASTM standards and CFR regulations, which define objective pass/fail criteria for physical and chemical properties. Biocompatibility tests rely on standard animal models and established methodologies, not expert consensus on individual cases.

4. Adjudication Method for the Test Set

This is not applicable. The evaluations are based on objective measurements against predefined standards, leaving no room for adjudication among experts.

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

No. This document does not mention any MRMC comparative effectiveness study. Such studies are typically relevant for diagnostic imaging devices where human interpretation is a key component.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not a software-based or AI-driven device. Its performance is entirely standalone in the sense that its physical and chemical properties are tested directly.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on established industry standards and regulations:

• ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
• 21 CFR 800.20 for freedom from pinholes (waterleak test).
• ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).

8. The Sample Size for the Training Set

This concept is not applicable to the device described. This is not an AI/ML device that requires a training set. The "training" for such a product involves adherence to manufacturing processes and quality control, not data-driven learning.

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