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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.

Non-Sterile, powdered latex examination gloves.

The acceptance criteria for the "Non-sterile, powdered latex examination gloves" and the study proving adherence to these criteria are detailed below.

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 sample sizes used for each specific test (e.g., freedom from pinholes, physical properties, etc.). It refers to "The performance test data of the non-clinical tests that support a determination of substantial equivalence" suggesting that tests were conducted.

The data provenance is not explicitly mentioned as country of origin but implies the tests were conducted by the manufacturer, Siam Sempermed Corp., Ltd, based in Thailand. The nature of the tests (e.g., ASTM standards for physical properties, animal studies for biocompatibility) indicates that these were likely prospective laboratory tests conducted to meet established standards for medical devices.

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

This information is not provided in the document. The "ground truth" for these tests is implicitly defined by the ASTM standards and the biological test methodologies. For example, "Passes" for Biocompatibility (Primary Skin Irritation in Rabbits) signifies that the results fell within the acceptable parameters defined by the test method, rather than being determined by expert consensus on specific device defects.

4. Adjudication method for the test set

Not applicable. The tests mentioned (e.g., ASTM D 3578-05, Primary Skin Irritation in Rabbits) are objective laboratory or animal studies with clear pass/fail criteria based on predefined specifications or biological responses. They do not involve human interpretation or adjudication in the sense of consensus building among experts.

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 device is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is irrelevant to its evaluation.

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

Not applicable. As this is a physical medical device, there is no algorithm or AI component to evaluate in a standalone capacity.

7. The type of ground truth used

The ground truth used for evaluating the device's performance is based on:

• Established Industry Standards: ASTM D 3578-05 for various physical characteristics (dimensions, physical properties, freedom from pinholes, powdered residue, protein level).
• Standardized Biological Test Methods: "Primary Skin Irritation in Rabbits" and "Guinea Pig Sensitization" for biocompatibility.

These methods define the objective criteria that the device must meet to be considered acceptable.

8. The sample size for the training set

Not applicable. This device is a physical medical product, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.

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

Not applicable, as there is no training set for this type of device.

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Class 1 Powdered Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for "Cashmere Non-Sterile, Powdered Latex Examination Gloves". Here's the information requested, extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states these figures were the average among the eight tested samples.

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

• Sample Size for Test Set: The document explicitly mentions "eight tested samples" for the physical properties (tensile strength and ultimate elongation). For watertightness, it references "GI AQL=2.5%", which implies a sampling plan defined by ASTM D3578-99 and FDA 1000 ml watertight test, but the specific number of gloves tested is not provided in this summary.
• Data Provenance: The study appears to be retrospective, as it's a summary of performance data collected to demonstrate compliance with existing standards (ASTM D3578-99 and FDA requirements). The manufacturer is Seal Polymer Industries Sdn. Bhd., located in Lahat, Perak, Malaysia.

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

Not applicable. This is a performance claim for a physical device based on standardized tests, not an AI/diagnostic device requiring expert ground truth establishment for medical image interpretation or similar. The "ground truth" is established by the specifications in ASTM D3578-99 and FDA requirements.

4. Adjudication method for the test set

Not applicable. As this involves physical testing against established standards, adjudication by experts for discordant results is not mentioned or typically relevant. The results are objective measurements or pass/fail criteria.

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 document describes a medical glove, not an AI-assisted diagnostic device.

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

Not applicable. This document describes a medical glove, not an algorithm.

7. The type of ground truth used

The ground truth for this device's performance is based on established industry standards and regulatory requirements:

• ASTM D3578-99 Standard
• FDA 1000 ml watertight test requirements
• FDA minimum powder residual content requirements
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test).

8. The sample size for the training set

Not applicable. This is a medical glove, not an AI device that requires a training set.

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

Not applicable. This is a medical glove, not an AI device that requires a training set.

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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 latex patient examination gloves 80LYY, powdered and meeting all the requirements of ASTM-D3578-99 Standard Specification for Latex Examination Gloves for Medical Application.

The provided text describes the acceptance criteria and performance data for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES, rather than a typical AI-driven device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set size, etc.) are not applicable to the documentation provided for this type of medical device clearance.

However, I can extract the relevant information regarding acceptance criteria and reported performance from the document.

Acceptance Criteria and Reported Device Performance for ROYAL SHIELD POWDERED LATEX EXAMINATION GLOVES

1. Table of Acceptance Criteria and Reported Device Performance

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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

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 Latex Patient Examination Glove 80 LYL, powdered with absorbable dusting powder, that meets all of the requirement of ASTM Standard D3578-95 and FDA Water Leak Test.

The provided text describes the acceptance criteria and the results of tests performed on "Evergreen Non-Sterile Powdered Latex Examination Gloves" to demonstrate their compliance with established standards.

Here's the information extracted and organized:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

• Water Tight Test:

  • Sample Size: 80 pieces of gloves per batch were tested.
  • Data Provenance: The testing was performed by YTY Industry (Manjung) Sdn Bhd (Malaysia). It appears to be retrospective testing of produced batches.

• Dimensional, Tensile Strength, and Elongation Tests:

  • The document does not explicitly state the sample size for these tests. It reports specific values for "YTY's Gloves" which implies samples were taken and tested, but the number of units is not provided.
  • Data Provenance: Presumably from internal testing conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia). Also appears retrospective.

• Biocompatibility Tests:

  • The document does not state the sample size.
  • Data Provenance: Not explicitly stated, but typically done by third-party labs. The document only states "The gloves pass the Biocompatibility Tests."

• Water Soluble Protein Test:

  • Sample Size: Not explicitly stated, but results are given for one "Batch No. Production Date."
  • Data Provenance: Presumably from internal testing conducted by YTY Industry (Manjung) Sdn Bhd (Malaysia).

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

• Not applicable. This document describes performance testing against established industry standards (ASTM D3578-95, FDA Water Leak Test, ASTM D5712, etc.) for physical and chemical properties of gloves. The "ground truth" is defined by these objective engineering and regulatory standards, not by expert consensus on subjective observations.

4. Adjudication Method for the Test Set:

• None. The tests described are objective measurements (dimensions, strength, elongation) or standardized pass/fail criteria (water leak, biocompatibility). There is no "adjudication" in the sense of multiple human reviewers resolving discrepancies in a subjective assessment. The water leak test uses an AQL (Acceptable Quality Level) sampling plan, which is a statistical method for determining acceptance based on defects, not expert adjudication.

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 document is for the premarket approval of a medical device (latex examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI comparison is relevant.

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

• Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used:

• The ground truth is based on established engineering and material science standards and regulatory requirements. Specifically:
  • ASTM D3578-95 Standard (for dimensions, tensile strength, ultimate elongation).
  • FDA Water Leak Test requirements (for integrity/holes).
  • ASTM D5151-90 Test method for Detection of Holes in Medical Gloves.
  • Biocompatibility test standards (Primary Dermal Irritation Test and Skin Sensitization Study, though specific standard numbers are not given here).
  • ASTM D5712 standards (for Water Soluble Protein Test).

8. The sample size for the training set:

• Not applicable. Since this is not an AI/machine learning model, there is no "training set." The glove manufacturing process is controlled to meet these pre-defined specifications through quality control and process validation.

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

• Not applicable. As there is no training set for an AI model, this question is not relevant. The "ground truth" for the product's performance is the adherence to the published ASTM and FDA standards.

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