Search Results

The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.

The subject device is powder free nitrile examination gloves. The glove is manufactured from nitrile. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand. The subject device is blue. The subject device is non-sterile, and single use device to prevent contamination between patient and examiner.

The subject device can be available in six specifications: XS、S、M、L、XL and XXL.

This document is a 510(k) Premarket Notification for Nitrile Patient Examination Gloves, which are Class I devices. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not involve AI or complex medical imaging analysis. Therefore, many of the requested elements (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of medical device submission.

Here's an analysis of the provided text in the context of the requested information, focusing on what is relevant and explicitly stated:

Device: Nitrile Patient Examination Gloves (K211434)

This product is a simple, non-sterile, disposable examination glove. Its acceptance criteria and performance are based on established physical, chemical, and biocompatibility standards for such devices, not on complex algorithmic performance like AI.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation is found in "Table 3 Performance Comparison" and the more detailed "Test Methodology" and "Results" table within Section 8.0 "Summary of Non-clinical Testing."

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

• Sample Size: The document provides specific sample sizes for certain tests within the "Results" section of the non-clinical testing summary:
  • Watertightness Test (ASTM D5151): Indicated by "2/125, 0/125, 0/125, 1/125, 0/125, 0/125 leaks." This suggests a sample size of 125 gloves per test run, with 6 runs shown (total 750 gloves tested for holes). However, the specific methodology of ASTM D5151 for an AQL of 2.5 involves sampling plans based on lot size, which isn't detailed here beyond the reported results.
  • Powder Content (ASTM D6124): Six data points (0.05, 0.06, 0.08, 0.07, 0.09, 0.06) are reported, suggesting 6 samples were tested.
  • Physical properties (ASTM D412): Results are shown across six sizes (XS, S, M, L, XL, XXL) for a range of values. The exact number of samples tested per size is not explicitly stated but implies multiple measurements per characteristic per size.
  • Biocompatibility (ISO 10993-5, ISO 10993-10): Specific sample numbers are not provided, as these are typically conducted in accordance with the standard, which defines the test methods and sample requirements.
• Data Provenance: Not explicitly stated, but implies the testing was conducted by the manufacturer or a contracted lab to generate data for the 510(k) submission. There is no indication of country of origin for the data itself outside of the manufacturer's location (Zhangjiagang, China). The data is by nature prospective, as it's generated specifically for the submission to prove compliance with standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is not an AI/imaging device. Ground truth for these criteria (e.g., tensile strength, presence of holes, cytotoxicity) is established by adherence to globally recognized, standardized test methodologies (ASTM, ISO) and laboratory measurements, not by expert human interpretation or consensus.

4. Adjudication Method for the Test Set

Not Applicable. See point 3. Testing involves objective, quantitative measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI/imaging device. No human-in-the-loop study or MRMC study was performed or required.

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

Not Applicable. This is not an AI/imaging device.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective, measurable criteria defined by international standards (ASTM, ISO). For example:

• Physical Dimensions: Measured directly using calibrated instruments against specified length, width, and thickness ranges.
• Physical Properties (Tensile Strength, Elongation): Measured using standardized mechanical testing equipment (e.g., universal testing machine) according to ASTM D412.
• Freedom from Holes: Determined by standardized watertightness test (filling with water and checking for leaks) according to ASTM D5151, with results evaluated against an Acceptable Quality Level (AQL).
• Powder Content: Measured gravimetrically according to ASTM D6124.
• Biocompatibility: Determined by laboratory tests (e.g., cell culture for cytotoxicity, animal/in-vivo tests for irritation/sensitization) according to ISO 10993 series.

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of machine learning or AI models. It's a manufactured product whose quality is assessed through conventional engineering and biological testing.

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

Not Applicable. See point 8.

Ask a specific question about this device