Search Results

Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

The provided text is an FDA 510(k) summary for "Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a medical device's performance against specific clinical efficacy or diagnostic accuracy criteria as would be required for a novel AI/imaging device.

Therefore, many of the requested categories (e.g., sample size for test/training set, number of experts, adjudication methods, MRMC studies, effect size, type of ground truth) are not applicable to this type of medical device submission. This submission relies on established performance standards for examination gloves.

Here's how the available information from the document applies to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document compares the subject device's performance against established ASTM standards and FDA requirements, as well as against the predicate device.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for pinholes, dimensions, etc.). However, it refers to "Inspection Level ILS-2 AQL 4.0" and "Inspection Level IAQL2.5" which are statistical sampling plans used in quality control (Acceptable Quality Levels). While these indicate a sampling methodology, the precise number of units sampled for each test is not explicitly stated.
• Data Provenance: The tests were performed on the subject device manufactured by Anhui Kindguard Medical Supplies Technology Co.,Ltd, located in China. The data would be derived from the manufacturing and quality control processes of the subject device. These are prospective tests performed on newly manufactured devices for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. For this type of device (patient examination gloves), "ground truth" is established through adherence to physical and chemical performance standards (e.g., ASTM standards for dimensions, tensile strength, freedom from pinholes, biocompatibility). These are objective measurements and laboratory tests, not subjective interpretations requiring multiple human experts.

4. Adjudication method for the test set:

• Not Applicable. Adjudication methods are typically relevant for subjective assessments (e.g., image interpretation where disagreements among readers need resolution). This submission relies on objective physical and chemical testing.

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 or imaging device. It's a physical medical device (examination gloves). Clinical performance data (including MRMC studies) was explicitly stated as not needed to demonstrate substantial equivalence, and "determination of substantial equivalence is not based on an assessment of clinical performance data."

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

• Not Applicable. This is not an algorithm based device.

7. The type of ground truth used:

• The "ground truth" here is defined by established consensus standards and regulatory requirements for patient examination gloves, specifically:
  • ASTM D5250-06 (Reapproved 2011) - Standard Specification for Poly(vinyl chloride) Patient Examination Gloves
  • ASTM D5151-06 (Reapproved 2011) - Standard Test Method for Detection of Holes in Medical Gloves
  • ASTM D6124-06 (Reaffirmation 2011) - Standard Test Method for Residual Powder on Medical Gloves
  • 21 CFR 800.20 - Tests for leakage of medical devices
  • ISO 10993-10: 2010-08-01 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
• The device's performance is objectively measured against the specifications outlined in these standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning or AI algorithm. The manufacturing process and quality control adhere to established standards, where the "training" analogous concept would be the development and adherence to manufacturing specifications and test methods.

9. How the ground truth for the training set was established:

• Not Applicable. As there's no training set, this question is not relevant. The "ground truth" for ensuring consistent product quality is embedded in the standardized manufacturing processes and quality control testing that align with the aforementioned ASTM and ISO standards.

Ask a specific question about this device