Search Results

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Sterile, Blue Color Powder Free Nitrile Examination Glove":

This document describes a 510(k) summary for a medical device, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. For such devices, the "acceptance criteria" are generally compliance with recognized standards and performance specifications, and the "study" is the testing conducted to show this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test within the "Summary of Performance Data." However, for gloves, industry standards like ASTM D6319-05 typically specify sampling plans (e.g., AQL levels for attributes like watertightness). The "Multiple Normal G1" indicated for the Watertight test likely refers to a sampling plan for inspection level G1.

The data provenance is from Malaysia (BIOGREEN YIELDS SDN. BHD. is located in Sitiawan, Perak, Malaysia). The nature of the tests (physical and chemical properties, bio-compatibility) indicates this data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this submission.

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

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is established by direct measurement of physical and chemical properties and biological reactions according to standardized protocols (ASTM D6319-05, FDA watertight test, bio-compatibility tests). Therefore, there were no human experts establishing ground truth in the context of interpretation; rather, qualified laboratory personnel would have conducted the tests according to established scientific methods.

4. Adjudication method for the test set

Not applicable for this type of device testing. Adjudication is relevant for subjective interpretations, often in diagnostic imaging, where multiple experts may disagree. Here, the tests are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a physical product (gloves) and does not involve AI or human "readers" in its performance evaluation.

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

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product and its performance is measured directly against established physical and chemical standards, not through an AI algorithm.

7. The type of ground truth used

The ground truth used is based on:

• Performance Standards/Specifications: Established by recognized standards organizations (ASTM D6319-05) and regulatory bodies (FDA 1000ml watertight test).
• Objective Measurements: Direct quantitative and qualitative measurements of physical properties (length, width, thickness, tensile strength, elongation), chemical properties (powder content, moisture content), and biological reactions (bio-compatibility tests).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning sense. The manufacturing process itself (which is subject to Good Manufacturing Practices) ensures consistency, but there's no data set used to "train" the product's performance.

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

Not applicable. As there is no training set for this physical device, there is no ground truth established for a training set.

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Class I Polyurethane Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D6319-00a8 and FDA Water leak test.

The provided document describes the acceptance criteria and performance of "MULTIPLE PRIVATE LABELS, NON-STERILE, POWDER-FREE POLYURETHANE, WHITE COLOR EXAMINATION GLOVES" by YTY Industry (Manjung) Sdn Bhd.

Here's a breakdown of the requested information:

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 specific sample sizes used for each test. It refers to the ASTM D6319-00a standard and FDA 1000ML watertight test, which would define the sampling plans. The data provenance is from Malaysia, specifically YTY Industry (Manjung) Sdn Bhd. The study appears to be prospective for the device being submitted, as it's testing the performance of their gloves against established standards.

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

This information is not provided in the document. The acceptance criteria are based on the ASTM D6319-00a standard and FDA watertest, which are established industry and regulatory standards, not expert consensus for this specific study.

4. Adjudication Method for the Test Set:

This information is not provided. The assessment appears to be based on direct measurement and comparison against defined thresholds in the ASTM standard and FDA test, rather than an adjudication process between human reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the physical and performance characteristics of a medical glove, not on the interpretation of medical images or data by human readers with or without AI assistance.

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

This question is not applicable as the device is a physical medical glove and not an algorithm or AI system. The performance tests are direct measurements of the glove's properties

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements. Specifically:

• ASTM D6319-00a: Standard Specification for Polyurethane Patient Examination Gloves.
• FDA 1000ML watertight test.
• Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization).

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product (medical glove), not an AI algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

Ask a specific question about this device

A 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.

VINYL EXAMINATION GLOVES, POWDER-FREE

This appears to be a 510(k) clearance letter from the FDA for Vinyl Examination Gloves, Powder-Free. This type of document does not contain the information requested in your prompt regarding acceptance criteria and study details.

The provided text simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information for the applicant.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or test results.
2. Sample size used for the test set and the data provenance: No device testing details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review details are provided.
4. Adjudication method for the test set: Not applicable as no test set details are provided.
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: This is a medical glove, not an AI diagnostic device, so an MRMC study is not relevant and not discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: No ground truth details are provided.
8. The sample size for the training set: Not applicable as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable as this is not a machine learning device.

The 510(k) process for devices like examination gloves primarily relies on demonstrating substantial equivalence to existing predicate devices, often through adherence to recognized standards (e.g., ASTM standards for glove performance). The detailed testing reports supporting this substantial equivalence are typically submitted by the manufacturer to the FDA but are not generally part of the publicly released 510(k) clearance letter itself.

Ask a specific question about this device

Ask a specific question about this device