Search Results

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner and the patient.

The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.

This document is a 510(k) Premarket Notification for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue. It demonstrates substantial equivalence to a predicate device (K112012). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance specifications of the glove and the testing conducted to show compliance with those specifications and equivalence to the predicate device.

Here's an breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several characteristics and their corresponding standards/performance for the new device (K162510) and the predicate device (K112012). This can be structured as follows:

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

• Sample Size: The document refers to "Inspection Level-S-2" and "Inspection Level-G-1" with associated AQLs (Acceptance Quality Limits) for various tests (e.g., Dimensions, Physical Properties, Freedom from Pinholes). These imply specific sampling plans outlined in the relevant ASTM standards (ASTM D 6319-10, ASTM D 5151-06, etc.). However, the exact number of units tested is not explicitly stated in this summary document.
• Data Provenance: Not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. As this is a premarket submission for a physical device, the testing would have been conducted in a lab environment.

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

• This is not applicable in the context of this device. This document is about a physical medical device (gloves), not an AI/software device requiring expert interpretation of medical images or data. The "ground truth" for glove performance is established by adherence to specified physical and chemical characteristics and recognized ASTM and ISO standards, not by expert consensus on clinical interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The "ground truth" is determined by objective physical and chemical testing methods (e.g., measuring dimensions, tensile strength, performing water leak tests, chemical residue analysis, biocompatibility assays), not through human adjudication of differing interpretations.

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

• No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human reader performance is a key metric. For examination gloves, the focus is on physical and chemical properties and safety/performance equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is not an algorithm or AI device. The "performance" is the inherent physical and chemical properties of the glove.

7. The Type of Ground Truth Used

• The ground truth for this device is based on objective, standardized measurements and test methods defined by recognized national and international standards, primarily ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. This includes:
  • Physical Specifications: Dimensions (length, width, thickness), tensile strength, elongation.
  • Functional Testing: Freedom from pinholes (water integrity).
  • Chemical Analysis: Powder residue.
  • Biocompatibility Testing: Dermal sensitization and primary skin irritation, conducted according to ISO 10993-10 and 16 CFR Part 1500.

8. The Sample Size for the Training Set

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

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

• Not applicable. As above, this is not a machine learning or AI device.

Ask a specific question about this device

The Non Sterile. Powder Free Nitrile Examination Gloves [{8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M)Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. This device is for over-the counter single use. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided document describes the performance data for various models of Non-Sterile, Powder Free Nitrile Examination Gloves from YTY Industry (MANJUNG) SDN. BHD. based on ASTM and FDA standards. This is not an AI/ML device, therefore, the information requested in points 2, 3, 4, 5, 6, 7, 8, and 9 are not applicable.

Here's the summary of the acceptance criteria and reported device performance:

1. A table of acceptance criteria and the reported device performance

Study Proving Device Meets Acceptance Criteria:

The study summarized in the document is a series of non-clinical tests performed on the Non-Sterile, Powder Free Nitrile Examination Gloves (across various models and colors).

• Standards Used: The performance of the devices was evaluated against the following standards:

  • ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application.
  • FDA 1000ml Water Leak Test (ASTM D5151-06 (2011) for watertightness with AQL GII 2.5).
  • ISO 10993-10 for Primary Skin Irritation and Dermal Sensitization (Biocompatibility).
  • ASTM-D6124-10 (Reapproved 2011) for Residual Powder.

• Test Results: The table above details the specific performance results for each characteristic, demonstrating that all tested models of the gloves met or exceeded the specified acceptance criteria for dimensions, physical properties (tensile strength, ultimate elongation, before and after aging), freedom from holes, powder-free status (moisture content, residual powder), and biocompatibility.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states for "Freedom from holes" that the sample size for the water leak test was 80 gloves per lot, with a lot size of 16,000 gloves. The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. However, the manufacturer is stated as YTY INDUSTRY (MANJUNG) SDN. BHD. from Malaysia. The tests are non-clinical, implying they were likely conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is not an AI/ML device. The ground truth is established by standardized testing protocols (ASTM, ISO, FDA tests), not by expert consensus in the human interpretation sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device is not an AI/ML device. The "ground truth" is determined by objective measurements and standardized testing procedures.

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 information is not applicable as the device is not an AI/ML device and human "readers" or interpretations are not part of its function or evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of these gloves is defined by objective measurements and adherence to international and national standards (ASTM, ISO, FDA specifications) for physical properties, barrier integrity, and biocompatibility. This includes measurements of length, width, thickness, tensile strength, elongation, freedom from holes (water leak test), moisture content, residual powder, and biological response (skin irritation and sensitization).

8. The sample size for the training set
This information is not applicable as the device is not an AI/ML device. There is no concept of a "training set" for physical products like examination gloves in this context.

9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML device.

Ask a specific question about this device

A powder-free 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.

Non sterile, Powder free Nitrile Examination Glove, Blue.

The provided text describes a 510(k) summary for a Non-sterile, Powder-free Nitrile Examination Glove, Blue. This is a medical device, and the information presented is for its regulatory clearance, not a study evaluating an AI device or a diagnostic tool. Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of device and its regulatory submission.

The document focuses on demonstrating that the new glove is "substantially equivalent" to an already legally marketed predicate device by meeting established performance standards.

Here's an analysis of the provided information, addressing the applicable categories:

1. Table of Acceptance Criteria and Reported Device Performance

Note: "ASTM D 6319-10" refers to "Standard Specification for Nitrile Examination Gloves for Medical Application," which outlines the specific acceptance criteria (e.g., minimum tensile strength, maximum pinhole AQL, etc.) for each characteristic. The document states the device "Meets" or "Passes" these standards.

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

• Sample Size: Not specified in the provided text. The testing for glove performance standards like ASTM D 6319-10 typically involves taking samples from production lots. The specific number of gloves tested for each characteristic (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM standard itself and quality control procedures, but this detail is not present in the 510(k) summary.
• Data Provenance: The manufacturer is Siam Sempermed Corp., Ltd, located in Songkhla, Thailand. Therefore, the data would have originated from their testing facilities in Thailand. The data is based on non-clinical performance testing of the device's physical and biocompatibility characteristics, conducted to demonstrate compliance with the ASTM standard. This is prospective data generated 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 (medical glove), "ground truth" is established by adherence to established, objective, and quantitative physical and chemical standards (e.g., ASTM D 6319-10, biocompatibility testing protocols). There are no human "experts" interpreting results like in an image analysis or diagnostic study to establish a ground truth in the typical sense. Laboratory technicians and quality control personnel perform the tests according to standardized protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication is typically used in studies where there is subjective interpretation or disagreement among observers (e.g., radiologists). For objective glove performance testing, the results are quantitative measurements compared directly against a standard. If a test fails, it fails; there is no 'adjudication' process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Not Applicable. MRMC studies are used to evaluate diagnostic performance with human readers. This document describes a physical medical device (a glove), not a diagnostic or AI-driven system.

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

• Not Applicable. This device is a physical product and does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective physical and chemical measurements compared against the acceptance criteria defined by recognized consensus standards, specifically ASTM D 6319-10 for physical properties, and standard biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization). These are quantitative, laboratory-based measurements.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not Applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

Ask a specific question about this device