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A patient examination glove is a disposable device intended for medical purposes that 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.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured as requested.

The document describes a 510(k) submission for Powdered (White) Vinyl Patient Examination Gloves. As such, the "device" in this context is a medical glove, not a software algorithm or AI system. Therefore, many of the requested points related to AI/software validation are not applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size in units is not provided, but AQL 4.0 refers to a sampling plan for acceptability).

• FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample size in units is not provided).

• Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically performed in vivo (on animal models or human volunteers). The context implies prospective testing specifically for this device.

• Residual Powder Test: Not explicitly stated, but performed at finished inspection.

  Data Provenance: The tests were conducted on the manufacturer's own gloves ("Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production"), indicating a prospective testing approach specific to this device. The country of origin of the manufacturer is China.

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

This information is not applicable as the device is a medical glove, not a diagnostic or prognostic system requiring expert interpretation or ground truth establishment in that typical sense. The "truth" here is determined by objective physical, chemical, and biological tests according to established standards.

4. Adjudication method for the test set:

Not applicable. This concept typically applies to subjective assessments where multiple human readers or experts evaluate data. For physical product testing, the methods are objective applications of test 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 relates to AI/software performance studies. The device is a physical medical glove.

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

Not applicable. This relates to AI/software performance studies. The device is a physical medical glove.

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

The "ground truth" for the glove's performance is established by objective measurements and chemical/biological assays demonstrating compliance with predefined ASTM standards and FDA requirements. For example:

• Physical properties (tensile strength, dimensions) are measured.
• Pinhole presence is determined by liquid leakage.
• Biocompatibility (skin irritation/sensitization) is assessed through standard biological testing.
• Residual powder is measured gravimetrically.

8. The sample size for the training set:

Not applicable. This concept refers to the data used to train an AI model. The device is a physical medical glove, not an AI system.

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

Not applicable. As above, this pertains to AI model development.

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A patient examination glove is a disposable device intended for medical purposes that 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.

A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

Here's a breakdown of the acceptance criteria and study information for the Ever Light Powdered (White) Vinyl Patient Examination Gloves, based on the provided text:

Device: Ever Light Plastic Products Co., Ltd. Powdered (White) Vinyl Patient Examination Gloves

Predicate Device: Shijiazhuang Great Eagle Plastic Products Co., Ltd Powdered (White) Vinyl Patient Examination Gloves (K000166)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
• Pinhole / Water Leak Test: Sampling AQL 2.5, inspection level I. (Specific number of units for the sample not provided, but these are statistical sampling plans.)
• Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size for the subjects/animals used in the tests.
• Residual Powder Test: "at finished inspection" (specific sample size not provided).

Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of product testing for a 510(k) submission, these would typically be prospective tests conducted by the manufacturer or contracted labs.

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

This type of information is not applicable to this submission. The tests performed are laboratory and material property tests (e.g., physical dimensions, water-fill, chemical analysis, biocompatibility tests), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by direct measurement against defined ASTM or FDA standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations in clinical studies. The tests described are objective, pass/fail or quantitative measurements against a standard.

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

No, an MRMC comparative effectiveness study was not done. This type of study is used to evaluate the diagnostic performance of a medical device (especially those involving image interpretation or clinical decision support) with and without AI assistance, typically involving human readers. The device in question is a patient examination glove, for which such a study is irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This refers to AI algorithm performance. The device is a physical product (gloves) and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established industry standards and regulatory requirements:

• ASTM-D-5250-00E4: For physical and dimensions testing.
• FDA 1000 ml. Water Fill Test: For pinhole detection.
• ASTM D-6124-06: For residual powder content.
• Biocompatibility testing guidelines: For primary skin irritation and sensitization.

Essentially, the "ground truth" is defined by these measurable standards and the outcome of the tests (e.g., whether a glove leaks, whether it irritates skin, whether it meets dimensional specifications).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for physical examination gloves. This concept applies to machine learning algorithms where data is used to train a model.

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

Not applicable. As there is no training set for this device type.

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A patient examination glove is a disposable device intended for medical purposes that 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.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00€4.

The provided document describes a 510(k) premarket notification for Powdered (White) Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML-based device and its performance. Therefore, the requested information pertaining to acceptance criteria and ground truth for an AI/ML device is not applicable in this context.

Here's a breakdown based on the information available:

The device in question is a medical glove, and the regulatory submission is a 510(k) aiming to show that it is "substantially equivalent" to an already marketed predicate device, not a novel AI/ML device requiring extensive performance studies as described in your request.

Here's why each of your requested points is not applicable or cannot be extracted:

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

   • Not Applicable: This document describes a physical medical device (gloves) and its compliance with established ASTM standards and FDA requirements for such devices, rather than performance metrics for an AI/ML algorithm. The acceptance criteria relate to physical properties and biocompatibility as per standards.

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

   • Not Applicable: The "tests" here are for physical properties, water integrity, and biocompatibility of gloves, not test sets for an AI/ML algorithm. The sample sizes mentioned are for inspection levels for attributes like pinhole defects (AQL 2.5, inspection level I) and residual powder, as well as general physical and dimensional testing (inspection level S-2, AQL 4.0). Data provenance for these types of tests typically refers to where the manufacturing and testing occurred (China, in this case), not detailed data provenance for an algorithm.

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):

   • Not Applicable: Ground truth as described (expert consensus, pathology) is not relevant for evaluating medical gloves. The acceptance is based on laboratory testing against established physical and biocompatibility standards.

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

   • Not Applicable: Adjudication methods are for clinical interpretation or labeling of images/data, which is not relevant for this device.

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 type of study is for evaluating diagnostic or interpretive AI/ML tools, not medical gloves.

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

   • Not Applicable: This device is not an algorithm.

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

   • Not Applicable: The "ground truth" for medical gloves is adherence to the specifications outlined in standards like ASTM D-5250-00E4 and FDA requirements for pinholes and biocompatibility.

8. The sample size for the training set:

   • Not Applicable: There is no training set for a physical medical device like gloves.

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

   • Not Applicable: There is no training set mentioned or implied.

In summary, the provided document describes a regulatory filing for a medical glove, demonstrating its substantial equivalence to a predicate device through conformity to established standards and physical/biocompatibility testing, not an AI/ML-driven medical device. Therefore, the questions related to AI/ML device acceptance criteria and studies do not apply.

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