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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 provided text describes the 510(k) summary for the Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. Powder Free (White) Vinyl Patient Examination Gloves.

This document is a premarket notification for a Class I medical device (patient examination gloves). The performance criteria and testing mentioned relate to the physical properties, biocompatibility, and acceptable quality levels (AQL) of the gloves, not to a digital algorithm or AI.

Therefore, many of the requested fields are Not Applicable in this context, as they pertain to the evaluation of AI/algorithm performance.

Here's a breakdown based on the provided information:

1. 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)

• Sample Size for Test Set:
  • For physical and dimensions testing: Inspection level S-2, AQL 4.0. (Specific sample size 'n' is not explicitly stated, but determined by an AQL table based on lot size and inspection level).
  • For FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample size 'n' is not explicitly stated).
  • For Primary Skin Irritation and Skin Sensitization: Not specified.
  • For Residual Powder Test: Not specified.
• Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., which is located in Shijiazhuang, Hebei, China. The testing would have been prospective to demonstrate compliance.

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. This device is a physical product (gloves), not an AI/algorithm. Ground truth is established through standardized physical, chemical, and biological tests, not expert consensus in the diagnostic sense. The "experts" would be laboratory personnel skilled in performing these specific ASTM and FDA test methods.

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

• Not Applicable. See point 3. Testing involves objective measurements against established standards, not interpretation or adjudication of diagnostic findings.

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 is a physical product, not an AI.

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

• Not Applicable. This is a physical product, not an AI.

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

• The "ground truth" for this device is based on established industry standards and regulatory requirements:
  • ASTM D-5250-00E4 standard specifications for vinyl patient examination gloves.
  • FDA 1000 ml Water Fill Test for pinhole detection.
  • ASTM D6124-06 for residual powder.
  • Biocompatibility testing guidelines (e.g., ISO 10993 series, though not explicitly cited, these tests adhere to such principles).

8. The sample size for the training set

• Not Applicable. This is a physical product. There is no concept of a "training set" in the context of device testing for physical properties. Production processes are monitored using statistical process control, which might involve continuous sampling, but not in the "training set" sense of an algorithm.

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

• Not Applicable. See point 8.

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

The provided text describes the submission for a Powder Free Vinyl Patient Examination Glove and does not contain information about an Artificial Intelligence (AI) device or a study that uses AI. Therefore, I cannot generate the requested information regarding AI device acceptance criteria, performance, or study details.

The document discusses the substantial equivalence of the glove to a predicate device based on physical and dimension testing (ASTM-D-5250-00 e4), a water fill test, primary skin irritation and sensitization testing, and a residual powder test. These are standard tests for medical gloves, not AI systems.

Therefore, the table and other detailed points you requested about AI device performance and studies cannot be extracted from this document.

Ask a specific question about this device

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.

While the provided text describes a medical device (Powdered Vinyl Patient Examination Gloves) and its regulatory approval process, it is not an AI/ML device. Therefore, many of the requested fields related to AI/ML device testing (e.g., ground truth, MRMC study, training set) are not applicable.

Here's the information that can be extracted or deduced from the provided text, adapted for a non-AI device:

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

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

• ASTM D-5250-00€4 (Physical and Dimensions Testing): "Inspection level S-2, AQL 4.0." (This specifies a sampling plan for quality control rather than a fixed "test set" size.)
• FDA 1000 ml. Water Fill Test: "samplings of AQL 2.5, inspection level 1." (Again, a sampling plan.)
• Primary Skin Irritation and Skin Sensitization: The number of subjects is not specified, but it's a "testing" conducted.
• Residual Powder Test: Not specified beyond being "conducted."

Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd. (China), based on specified ASTM standards and FDA requirements. The data is retrospective for the purpose of this 510(k) submission, as it describes tests already performed to demonstrate substantial equivalence.

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

Not applicable, as this is a physical medical device. The "ground truth" for its performance is determined by established physical and biological testing methods (e.g., water leak test, tensile strength tests, irritation tests) as per industry standards (ASTM) and regulatory requirements (FDA). There is no "ground truth" established by human experts in the way an AI diagnostic device would require.

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

Not applicable. Testing is based on objective measurements and established pass/fail criteria from standards. There is no human adjudication process involved in determining device performance against these physical and biological 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, as this is a physical medical device, not an AI/ML diagnostic or assistive device.

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.

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

The "ground truth" for this device is based on objective measurement standards defined by ASTM (e.g., D-5250-00€4 for physical properties like dimensions, tensile strength, elongation, and D-6124-06 for residual powder) and regulatory compliance tests (e.g., FDA 1000 ml Water Fill Test for pinholes, biocompatibility testing for irritation/sensitization). There isn't "ground truth" in the diagnostic sense; rather, it's about meeting pre-defined performance specifications.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

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.

This document describes the testing and acceptance criteria for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (Yellow) Vinyl Patient Examination Gloves.

Here is the 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

• Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level I" - The exact sample size is not explicitly stated, but it would be determined by the AQL and inspection level, referencing ISO 2859-1 or a similar standard.
• Physical Dimensions & Quality System: "Inspection level S-2, AQL 4.0" - Similar to the pinhole test, the exact sample size is not explicitly stated.
• Biocompatibility & Residual Powder: Sample sizes were not specified in the provided document.
• Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., in China. The data would be considered retrospective as it was conducted on finished products for regulatory submission.

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

Not applicable. This device is a medical glove, and its performance is evaluated against engineering standards and material properties, not through expert human interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against established standards (e.g., water fill for pinholes, chemical analysis for powder, physical measurements for dimensions). No human adjudication of differing interpretations is required.

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 typically used for diagnostic devices that involve human interpretation of results (e.g., radiology images), not for a medical device like an examination glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described is effectively standalone performance. The device's characteristics (physical properties, absence of pinholes, biocompatibility, powder residue) were measured directly without human intervention or interpretation that would alter the test outcome.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Industry Standards: Adherence to ASTM standard D-5250-00E4 for physical and dimensional characteristics, and ASTM D-6124-06 for residual powder.
• Regulatory Requirements: Adherence to FDA's 1000 ml. Water Fill Test for pinholes, and biocompatibility testing requirements.
• Objective Measurements: These standards and requirements define objective, measurable performance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The product is manufactured and then tested for compliance.

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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