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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, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

The document describes the acceptance criteria and the study conducted for the Shijiazhuang Junfei Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical Performance (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0" is mentioned, which refers to a sampling plan for attributes. The exact numerical sample size is not explicitly stated in the provided text, but it indicates a statistical sampling approach.
• Barrier Integrity (FDA 1000 ml. Water Fill Test): "samplings of AQL 2.5, inspection level I" is mentioned, again referring to a statistical sampling plan. The exact numerical sample size is not explicitly stated.
• Biocompatibility (Skin Irritation and Sensitization): The specific sample sizes for these tests are not provided in the document.
• Residual Powder Test (ASTM D6124-06): The specific sample size for this test is not provided.
• Data Provenance: The tests were conducted internally by Shijiazhuang Junfei Plastic Products Co., Ltd. (or on their behalf) as part of their production and quality control processes. The origin of the data is China, and it appears to be a prospective set of tests conducted on manufactured glove batches.

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

This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based, and standard-driven (e.g., ASTM standards, FDA water fill test), which do not typically require expert consensus for establishing ground truth in the same way clinical imaging or diagnostic studies might.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. The assessment of polyvinyl examination glove performance is based on defined physical and chemical test methods against established pass/fail criteria, not on subjective expert review or 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:

This information is not applicable. The device is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used:

The ground truth for this device is based on objective measurements against established industry standards and regulatory requirements. This includes:

• Physical properties defined by ASTM D-5250-00E4 (e.g., dimensions, tensile strength, elongation).
• Barrier integrity (pinhole detection) verified by the FDA 1000 ml. Water Fill Test.
• Biocompatibility based on standardized biological tests for primary skin irritation and sensitization.
• Chemical residue (powder content) measured according to ASTM D6124-06.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a manufactured product undergoing quality control and performance testing, not a machine learning model that requires a "training set."

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

This information is not applicable. As explained above, there is no "training set" in the context of this device. The ground truth for evaluating the device's performance is established by the specified ASTM standards and FDA test methods.

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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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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device