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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 Hospital and Personal Use Device panel as Class I. 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text describes a 510(k) premarket notification for "Powder Free Vinyl Patient Examination Gloves" and is not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, sample size, and expert involvement for AI/ML device testing is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and FDA requirements for patient examination gloves.

However, I can extract the closest analogous information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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A patient examination glove is disposable non-sterile 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 Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text is a 510(k) summary for a medical device: "Shijiazhuang Great Vision Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves". This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with AI assistance. As such, many of the requested categories for AI-assisted device studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted or deduced from the provided text, and noted where information is not applicable (N/A) for this type of device and submission:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. No specific number of gloves tested is provided.
   • Pinhole (Water Fill Test): AQL 2.5, inspection level I. No specific number of gloves tested is provided.
   • Primary Skin Irritation and Skin Sensitization: Not specified in terms of number of subjects or samples.
   • Residual Powder Test: Not specified in terms of number of gloves tested.
   • Data Provenance: Not explicitly stated, but the testing was performed by "Shijiazhuang Great Vision Plastic Products Co., Ltd." in China.

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

   • N/A. This is a submission for an examination glove, not an AI-assisted diagnostic device requiring expert interpretation of medical images or data. The testing involves standardized quality control and biocompatibility tests.

3. Adjudication method for the test set:

   • N/A. Adjudication methods like 2+1 or 3+1 are typical for studies involving human interpretation of medical data (e.g., radiology reads) where there might be disagreement among experts. For glove testing, the criteria are objective and defined by ASTM standards and FDA tests.

4. 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:

   • N/A. This is not an AI-assisted device.

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

   • N/A. This is not an AI-assisted device.

6. The type of ground truth used:

   • The "ground truth" for this device's performance evaluation is established through adherence to recognized industry standards (ASTM D-5250-06e1 for physical properties, ASTM D-6124-06 for residual powder) and FDA-specific testing protocols (1000 ml. Water Fill Test), as well as biocompatibility testing standards. These are objective measures and pass/fail criteria defined by these standards.

7. The sample size for the training set:

   • N/A. This is not an AI-assisted device that requires a training set. The descriptions relate to manufacturing quality control and product testing.

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

   • N/A. No training set is applicable 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 a 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, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document describes the 510(k) submission for Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic (White) Vinyl Patient Examination Gloves-Powder Free. As such, the "device" in this context refers to these examination gloves. The studies described are primarily non-clinical, focusing on manufacturing standards and material properties rather than clinical performance (e.g., diagnostic accuracy of an AI algorithm).

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 for each test performed (e.g., how many gloves were tested for pinholes, or how many subjects for skin irritation). It refers to:

• Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (These are sampling plans from quality control standards, implying a specific number of gloves would be inspected from a lot, but the exact number isn't given).
• FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Similarly, a sampling plan).
• Primary Skin Irritation and Skin Sensitization: The number of subjects is not specified.
• Residual Powder Test: Not specified.

Data Provenance: Not explicitly stated, but the tests were conducted by or for the manufacturer, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China.

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

Not applicable. This device is a physical product (gloves), not an AI/diagnostic device that relies on expert interpretation for ground truth establishment. The "ground truth" here is defined by physical and chemical properties and patient safety endpoints, measured by established testing methods.

4. Adjudication Method for the Test Set

Not applicable. Since the tests are objective measurements against predefined standards (e.g., water leak, powder content, skin reaction), there is no need for expert adjudication in the way it would be applied to subjective image interpretation or clinical diagnosis.

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

Not done. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Standardized Physical Measurements: Adherence to ASTM-D-5250-00 for physical properties and dimensions, and ASTM D6124-01 for residual powder.
• Biocompatibility Testing: Results from primary skin irritation and sensitization tests.
• FDA Pinhole Requirements: Passing the FDA's 1000 ml Water Fill Test.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance, not data training in a computational sense.

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

Not applicable. As there is no training set in the context of an AI device, no ground truth needs to be established for it.

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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 a 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. Powdered Nitrile Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.

The provided text describes the 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves. This product is a Class I medical device and, as such, the acceptance criteria and study information provided mainly pertain to meeting established industry standards for physical properties and biocompatibility, rather than advanced AI/software performance metrics.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels."

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

The document mentions "samplings" for the FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level G-1) and "inspection" for Physical and Dimensions Testing (Inspection Level S-2, AQL 4.0). For Residual Powder testing, it refers to "finished inspection."

• Specific sample sizes in units (e.g., number of gloves) are not explicitly provided. The AQL (Acceptable Quality Limit) levels refer to a statistically determined sampling plan, not a fixed number.
• Data Provenance: The tests were performed on the manufacturer's gloves, Shijiazhuang Great Vision Plastics Products Co., Ltd., based in Hebei Province, P.R. China. The testing was conducted as part of the manufacturing and submission process, implying it is prospective with respect to the regulatory submission.

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

• Not applicable for this type of device. The "ground truth" for glove performance is established by meeting objective, standardized physical and chemical test specifications (e.g., ASTM standards, FDA water fill test). There is no "expert consensus" on an image or clinical finding for this device.
• Biocompatibility tests (Primary Skin Irritation and Skin Sensitization) are typically evaluated by qualified toxicologists or dermatologists, but the number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not applicable. The tests involve objective measurements and pass/fail criteria based on quantitative standards, not subjective interpretations requiring adjudication.

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

• No, this is not applicable. This device is a patient examination glove, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

• Not applicable. This device is a physical product (glove), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device consists of:

• Industry Standards: ASTM Standard D6319-00a1 (for physical and dimensional properties).
• Regulatory Test Methods: FDA 1000 ml. Water Fill Test (for pinhole detection).
• Biocompatibility Standards: Implicitly, standards for evaluating skin irritation and sensitization.
• Specific Test Methods for Material Properties: ASTM D6124-01 (for residual starch powder).

8. The Sample Size for the Training Set

• Not applicable. This product is a physical medical device, not a machine learning model. 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, this question is not relevant.

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 a 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, Powder-Free Vinyl Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.

The provided document is a 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powder Free (Blue) Nitrile Patient Examination Gloves. This product is a Medical Device, not an AI/ML device. Therefore, the specific information requested about acceptance criteria, study details, and AI/ML specific aspects (like multi-reader multi-case studies, standalone performance, training/test sets, and ground truth establishment) is not applicable to this submission.

However, I can extract the acceptance criteria and the results of the non-clinical tests performed to demonstrate substantial equivalence, which is the analogous information for this type of device.

1. Table of acceptance criteria and the reported device performance

Ask a specific question about this device

Ask a specific question about this 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 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 800.6250. Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves.

Important Note: The provided document is a 510(k) summary for a medical device (patient examination gloves). For this type of device, the "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device and meeting established performance standards (ASTM). This is different from the acceptance criteria and studies for AI/ML-driven diagnostic devices, which often involve sensitivity, specificity, and reader studies.

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size:
     • For Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific number of gloves not stated, but defined by AQL statistical sampling plan).
     • For FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. (Specific number of gloves not stated, but defined by AQL statistical sampling plan).
     • For Primary Skin Irritation and Skin Sensitization: Not specified in the summary.
   • Data Provenance: Not explicitly stated, but implied to be from testing conducted by Shijiazhuang Great Vision Plastics Products Co., Ltd. in China, as manufacturing and submission are from this company. The studies are likely prospective, as they are part of the premarket submission process to demonstrate compliance.

2. 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 is not applicable in the context of device performance testing for examination gloves. "Ground truth" is established by adherence to clear, measurable engineering and biological standards (ASTM D5250-92, FDA water fill test, biocompatibility protocols) rather than expert human interpretation of complex data.

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

   • Not applicable. Performance is determined by objective physical and chemical tests against defined standards, not by human interpretation requiring adjudication.

4. 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 device is an examination glove, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

   • Not applicable. This device is an examination glove, not an algorithm.

6. 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 testing protocols:
     • ASTM Standard D5250-92 (for physical characteristics)
     • FDA 1000 ml. Water Fill Test (for pinhole/barrier integrity)
     • Biocompatibility testing protocols (for skin irritation and sensitization)

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "training" for manufacturing would be quality control and process adherence.

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

   • Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for manufacturing quality assurance is established through the continuous adherence to the standards and specifications listed above, enforced through ongoing quality management systems.

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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.

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.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 800,6250, Powder-Free Vinvl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-92.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shijiazhuang Great Vision Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0 (The exact number of gloves tested is not specified but is a standard sampling plan based on lot size).
  • FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5 (The exact number of gloves tested is not specified but is a standard sampling plan based on lot size).
  • Primary Skin Irritation and Skin Sensitization: Not specified, but generally involves human subjects or animal models.
  • USP Iodine Test: Not specified, but performed during finished inspection.
• Data Provenance: Not explicitly stated, but the submission is from a company in P.R. China, implying the testing likely occurred there or at a contract lab. The studies would be considered prospective as they were conducted specifically to demonstrate compliance for this device.

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

This type of medical device (patient examination gloves) does not typically involve "experts" in the sense of clinicians establishing ground truth for performance, as would be the case for diagnostic imaging or AI devices. The ground truth is established by standardized testing methods and regulatory limits (e.g., maximum acceptable pinhole rate, absence of irritation).

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective, standardized laboratory and physical tests, not subjective assessments requiring adjudication.

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 relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance might improve their performance. This device is a physical barrier protection, not a diagnostic tool.

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

Not applicable. This device is a physical product, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance (e.g., pinhole rate, tensile strength) is inherently "standalone" in that it's measured directly from the product.

7. The Type of Ground Truth Used:

The ground truth for this device is based on established industry standards and regulatory requirements, specifically:

• ASTM Standard D5250-92: Defines physical properties, dimensions, and testing methods for vinyl patient examination gloves.
• FDA 1000 ml. Water Fill Test: A regulatory standard for assessing pinhole defects.
• Biocompatibility Standards: Implicitly covered by Primary Skin Irritation and Skin Sensitization testing, aiming for a lack of adverse biological reactions.
• USP Iodine Test for Starch: A standard method to verify "powder-free" claims.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI algorithm, so 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 this type of device.

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