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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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the medical device:

The provided document describes the 510(k) summary for "Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves." This is a regulatory filing for a Class I medical device, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies in the same way a novel high-risk device would.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions specific inspection levels and AQLs (Acceptable Quality Levels) for certain tests, which imply statistical sampling.

• Pinhole FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I.
• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0.
• Residual Powder Test: Based on ASTM D-6124-06.

The exact number of units sampled for each test is not explicitly stated as a single "sample size" in this document, but rather referred to by AQL and inspection levels, which are methods for determining sample size based on lot size in quality control.

Data Provenance: The tests were conducted on gloves produced by Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. in China. The study is inherently prospective in the sense that the manufacturer performs these tests as part of their quality control and regulatory submission for the specific device being produced to demonstrate compliance.

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

• No external "experts" were used to establish ground truth in the context of comparative clinical evaluation for the acceptance criteria listed.
• The nature of these acceptance criteria (physical properties, biocompatibility, pinhole integrity, residual powder) means that the "ground truth" is established by adherence to pre-defined ASTM standards and FDA test methods. The performance is measured against these objective standards.
• The tests themselves would have been conducted by technicians or laboratory personnel, but their qualifications are not detailed, nor are they "experts" establishing a ground truth in the sense of clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple human readers interpret data (e.g., images) and their disagreements need to be resolved to establish a consensus ground truth. For the physical and chemical tests described here, the results are objective measurements against established standards, not subjective interpretations requiring adjudication.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for patient examination gloves, which are assessed based on their physical properties, barrier integrity, and biocompatibility, not on their interpretive performance or human reader interaction with an AI system.

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

Not applicable. This device is a physical product (gloves) and does not involve an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for these acceptance criteria is based on:

• External Standards and Test Methods: Primarily ASTM standards (D-5250-00E4, D-6124-06) and FDA test methods (e.g., 1000 ml. Water Fill Test).
• Objective Measurements: These standards define measurable properties (e.g., tensile strength, elongation, dimensions, pinhole count, residual powder quantity).
• Biocompatibility Testing Protocols: Standardized animal or in-vitro tests for skin irritation and sensitization.

8. The Sample Size for the Training Set

Not applicable. This is a conventional medical device (gloves), not an AI/ML powered device. There is no "training set." The manufacturing process itself could be considered "trained" through quality control and adherence to standards over time, but not in the machine learning sense.

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

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 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.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Ever Light Plastic Products Co., Ltd. Powdered (Yellow) Vinyl Patient Examination Gloves.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size for Physical and Dimensions Testing: Not explicitly stated as a fixed number, but refers to "samplings" and an "inspection level S-2" with "AQL 4.0". This implies a statistical sampling plan rather than a fixed sample size.
• Sample Size for Pinholes (Water Fill Test): Refers to "samplings of AQL 2.5, inspection level I". This also implies a statistical sampling plan.
• Sample Size for Primary Skin Irritation and Skin Sensitization: Not explicitly stated.
• Sample Size for Residual Powder Test: Not explicitly stated.
• Data Provenance: The studies were conducted by Ever Light Plastic Products Co., Ltd. for their product. It is a prospective evaluation of their manufactured gloves. The country of origin of the data would be China, where the manufacturer is located.

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 to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols (e.g., ASTM standards, FDA water fill test) and expert judgment is not typically involved in the same way it would be for diagnostic imaging or clinical outcomes studies. The reported performance is based on direct measurements and observations during these tests.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., by multiple readers) to resolve discrepancies. For objective performance measures of medical gloves, such as physical properties, leak tests, or biocompatibility, direct measurements are taken, and no adjudication by multiple experts is required.

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. This submission is for a medical device (patient examination gloves) that is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is irrelevant.

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

This information is not applicable. As mentioned above, this is not an AI algorithm. The performance evaluation is of the physical and biological characteristics of the gloves themselves.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Performance specifications and testing methods outlined in ASTM-D-5250-00E4.
• FDA requirements for pinholes (1000 ml. Water Fill Test).
• Standardized biocompatibility testing for irritation and sensitization.
• Standardized testing method for residual powder (ASTM D-6124-06).

These standards define the acceptable range or threshold for each property, forming the objective "ground truth" for compliance.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of physical medical devices like examination gloves. The manufacturing process of gloves is not an AI model that requires training data. Instead, there are quality control and acceptance sampling processes during manufacturing.

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

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

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Ask a specific question about this device

Ask a specific question about this device

A 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.

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.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

This submission describes the clearance of "Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves-Powdered" manufactured by SHIJIAZHUANG GREAT EAGLE PLASTICS PRODUCTS CO., LTD. This is a Class I medical device (21 CFR 880.6250) and is intended for medical purposes to prevent contamination between patients and examiners. The device's performance was evaluated against ASTM Standard D5250-92 and FDA's 1000 ml water fill test.

Here’s a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size:
  • For Physical and Dimensions Testing: AQL 4.0, Inspection Level S-4 (Specific number of gloves not provided, but AQL and inspection level define the sampling plan).
  • For FDA 1000 ml Water Fill Test: AQL 2.5, Inspection Level S-4 (Specific number of gloves not provided, but AQL and inspection level define the sampling plan).
  • For Primary Skin Irritation and Skin Sensitization: Not specified, but generally follows standard biological evaluation protocols.
• Data Provenance: Not explicitly stated, but assumed to be generated by the manufacturer or a contract research organization in China, as the manufacturer is based in Shijiazhuang, Hebei Province, P.R. China. The studies are prospective, conducted specifically for this submission.

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

• Not applicable. For this type of device (patient examination gloves), "ground truth" is established through standardized physical, chemical, and biological performance tests rather than expert interpretation of medical images or clinical data. The tests are objective measurements against established criteria.

4. Adjudication Method for the Test Set:

• Not applicable. As the "ground truth" is based on objective measurements from standardized tests, there is no need for expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

• No. An MRMC study is not relevant for this device. It is generally used for evaluating diagnostic devices where human readers interpret medical data.

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

• Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Its performance is evaluated through physical and biological testing.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance evaluation of the gloves is based on:
  • Standardized Test Methods: Adherence to ASTM D5250-92 for physical properties and dimensions.
  • Regulatory Test Methods: Compliance with the FDA 1000 ml Water Fill Test for barrier integrity (pinhole detection).
  • Biocompatibility Testing: Results from Primary Skin Irritation and Skin Sensitization tests.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm; 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 for an AI/ML algorithm.

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