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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.

POWDERED VINYL EXAM GLOVES, WHITE

This document describes the acceptance criteria and study proving a device meets these criteria. The device is 'Powdered Vinyl Exam Gloves, White' (K031104) from Glormed International, Inc.

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. However, the tests referenced are recognized industry standards for gloves.

• Data Provenance: The document does not specify the country of origin of the data. It implies the data was collected as part of the regulatory submission process. The study appears to be prospective in the sense that the tests were conducted specifically to demonstrate compliance for this device.

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

This information is not provided in the document. The "ground truth" for this type of device is established by meeting the specified performance standards rather than expert consensus on individual observations.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective measurements against established technical standards, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not relevant for this type of medical device (examination gloves). Such studies are typically conducted for diagnostic imaging devices where human interpretation plays a role.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study is not applicable as this is a physical medical device (gloves), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective measurements and adherence to established industry-specific performance standards (e.g., ASTM, ISO, MIL Std for physical properties, and specific bio-compatibility tests). There is no "expert consensus," "pathology," or "outcomes data" in the conventional sense for proving the functional performance of examination gloves.

8. Sample Size for the Training Set

There is no training set for this type of device. The device's performance is evaluated against predefined standards, not by training an algorithm.

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

This is not applicable as there is no training set for this device.

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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.

POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ

This is a 510(k) Summary for Powdered Vinyl Exam Gloves.
Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not applicable as the evaluations were based on standardized performance tests rather than expert interpretation of medical data or images.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluations were based on standardized performance tests rather than human interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a medical glove, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not conducted as this device is a medical glove, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on the objective measurements and pass/fail criteria defined by the listed industry and regulatory standards (ASTM, ISO, MIL Std, and bio-compatibility tests).

8. Sample Size for the Training Set

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a training set. The "ground truth" for demonstrating performance was established by the predefined specifications within the referenced ASTM, ISO, and MIL standards, and bio-compatibility testing procedures.

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.

POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ. 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.

The provided text describes the regulatory clearance for "POWDERED VINYL EXAM GLOVES, WHITE" (K030927) and references its substantial equivalence to another device (K021961). The acceptance criteria for medical gloves are typically defined by recognized standards such as ASTM. The document states that the device met or exceeded specific ASTM standards and other tests.

Here's the breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). This information is typically detailed in the full test reports, which are not included here.

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 provided in the document. Testing for medical gloves (physical properties, biocompatibility) typically involves laboratory testing against established standards, not necessarily relying on expert "ground truth" panels in the same way an AI diagnostic tool might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the type of device and testing described. The performance is assessed against standardized objective measurements defined by ASTM, ISO, and MIL standards, not subjective 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

No such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI, which is not the case for examination gloves.

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

This is not applicable for an examination glove. There is no algorithm or AI component in this device. The device itself (the glove) is the standalone entity being evaluated for its physical and biocompatibility properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for examination gloves is defined by the objective, measurable performance requirements specified in the referenced ASTM, ISO, and MIL standards for physical properties (e.g., tensile strength, elongation, barrier integrity) and validated laboratory tests for biocompatibility (dermal sensitization, primary skin irritation, bioburden).

8. The sample size for the training set

This is not applicable as this device is an examination glove and does not involve a "training set" in the context of machine learning or AI.

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

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

Ask a specific question about this device