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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Powder Free, Non-Sterile, Non Colored

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily discusses regulatory compliance and the substantial equivalence determination for the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study to prove the device meets those criteria based on the given text.

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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, 80L YZ, and meets all requirements of ASTM Standard D5250-00.

The provided 510(k) summary is for a medical device that is a Synthetic Powder Free Vinyl Patient Examination Glove. This type of submission, especially for Class I devices like examination gloves, typically relies on established performance standards rather than complex clinical studies involving human readers or AI.

Therefore, many of the requested categories regarding AI, human readers, ground truth for training sets, etc., are not applicable to this specific submission. The submission focuses on demonstrating that the new device meets recognized industry standards and is substantially equivalent to a predicate device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • For Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (Specific sample size is not explicitly stated, but these are statistical sampling plans from ASTM/ISO standards).
  • For FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I" (Specific sample size is not explicitly stated, but these are statistical sampling plans from ASTM/ISO standards).
  • For Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not specified but typically involves a set number of animal or in vitro tests according to ISO 10993 standards.
  • For Residual Powder Test: Not specified but would be a sampling from production batches.
• Data Provenance: The tests are described as being "conducted" in relation to the manufacturer (Shijiazhuang Eversharp Plastics Products Co., Ltd. in China), indicating the data provenance is likely internal testing performed by or for the manufacturer. The date of "May 11, 2001" for the summary indicates a retrospective nature relative to the submission date.

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

• Not Applicable. This device is a physical product (gloves) and its performance is assessed against standardized physical, chemical, and biological tests, not against diagnostic "ground truth" established by human experts in the way AI algorithms are evaluated.

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

• Not Applicable. As mentioned above, the evaluation is based on objective measurements and adherence to established standards, not on human interpretation or adjudication methods.

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 not an AI-enabled diagnostic device.

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

• Not Applicable. This is not an AI-enabled device.

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

• The "ground truth" for this device's performance is derived from established industry standards and regulatory test methods. For example:
  • Physical performance: Defined by ASTM-D-5250-00 (e.g., tensile strength, elongation, dimensions).
  • Barrier integrity: Defined by the FDA 1000 ml. Water Fill Test (pinhole detection).
  • Biocompatibility: Defined by primary skin irritation and skin sensitization tests (aligned with ISO 10993 principles, though not explicitly stated as such, it's the standard for these tests).
  • Powder content: Defined by ASTM D6124-97.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device. The "training" for the manufacturing process would be related to quality control and process validation, not data used to train an algorithm.

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 algorithm, this question is not relevant. The "ground truth" for manufacturing quality and consistency is established through adherence to Good Manufacturing Practices (GMP) and quality system regulations (such as 21 CFR Part 820), which ensure consistent product quality, but this is distinct from ground truth for an AI training set.

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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.

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 D5250-92.

This document describes the acceptance criteria and the study conducted for the Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through its conformance to established standards and tests for examination gloves.

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

• Sample Size:

  • For Physical and Dimensions Testing: Inspection Level S-2.
  • For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, Inspection Level S-4.
  • For Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but standard biocompatibility testing involves a statistically relevant number of subjects/samples.
  • For USP Iodine Test: Routinely performed at finished inspection; specific sample size per batch not provided.

• Data Provenance: The studies were conducted by the device manufacturer, Shijiazhuang Hongxiang Plastics Products Co., Ltd., based in P.R. China. The studies are retrospective relative to the submission date, as they were performed to demonstrate compliance of existing product batches.

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

This device is a medical glove, and the "ground truth" for its performance is established by objective, standardized laboratory and materials testing, not by expert interpretation of medical images or conditions. Therefore, the concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. The "experts" involved would be qualified laboratory technicians and material scientists who conduct the tests according to published ASTM and FDA standards. Specific numbers or qualifications of these individuals are not provided in the summary.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic assessments, particularly in imaging studies. For this device, the tests are primarily objective measurements against predefined thresholds set by ASTM standards and FDA guidelines (e.g., AQL levels for pinholes, pass/fail for irritation). Therefore, an adjudication method for conflicting expert opinions is not applicable. The results are quantitative or clearly pass/fail.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's effect on human performance is being evaluated. This device is an examination glove, which does not involve human interpretation in the same way.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The document describes several tests performed directly on the device (the gloves) to demonstrate its intrinsic properties and compliance with standards, independent of human interaction for interpretation purposes. These include:

• Physical and Dimensions Testing against ASTM D5250-92.
• FDA 1000 ml. Water Fill Test (for pinholes).
• Primary Skin Irritation testing.
• Skin Sensitization testing.
• USP Iodine Test for starch.

7. Type of Ground Truth Used

The ground truth used is primarily objective performance metrics and compliance with established industry standards and regulatory requirements. This includes:

• ASTM Standard D5250-92: For physical properties and dimensions.
• FDA 1000 ml. Water Fill Test requirements: For pinhole integrity.
• Biocompatibility guidelines: For primary skin irritation and sensitization.
• USP Iodine Test methodology: For confirming "powder-free" claims.
  These are well-defined, quantitative, or qualitative pass/fail criteria, rather than subjective expert consensus or pathology interpreted from patients.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. This device is a physical product (medical glove) and does not employ an AI algorithm or machine learning. Therefore, there is no training set in the context of AI development. The "training" for the manufacturing process involves adherence to Good Manufacturing Practices (GMP) and quality control, but not a data-driven training set for an AI model.

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

As stated in point 8, there is no training set for an AI algorithm. The manufacturing process and quality control for the gloves are based on established manufacturing specifications, material science principles, and quality assurance protocols that ensure the product consistently meets the performance standards outlined in Section 7.

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.

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, Powder-Free Vinyl 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 the study proving the device meets them, structured as requested:

Device: Shijiazhuang Dilly Plastics Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves

Acceptance Criteria and Device Performance:

Study Details:

• Sample size used for the test set and the data provenance:

  • ASTM D5250-92 Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0." (Specific sample size not explicitly stated, but determined by the AQL level for lots.)
  • FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level S-4." (Specific sample size not explicitly stated, but determined by the AQL level for lots.)
  • Primary Skin Irritation and Skin Sensitization Testing: Not explicitly stated.
  • USP Iodine Test for Starch: Not explicitly stated.
  • Data Provenance: The document implies in-house testing conducted by Shijiazhuang Dilly Plastics Products Co., Ltd. in P.R. China, presumably on newly manufactured gloves. This would be considered prospective for the specific batches tested.

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

  • The document describes performance against established industry standards (ASTM D5250-92) and FDA test methods (1000 ml. Water Fill Test, USP Iodine Test), as well as biocompatibility testing. It does not mention expert consensus for establishing ground truth in the context of diagnostic interpretation. Ground truth for these criteria is defined by the objective pass/fail parameters outlined in the respective standards and test methodologies.

• Adjudication method for the test set:

  • No adjudication method (like 2+1, 3+1) is mentioned as this is not a study involving subjective interpretations (e.g., image reading). The tests are objective measurements against defined criteria in standards.

• 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:

  • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical examination glove, not an AI-powered diagnostic or assistive tool for human readers.

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

  • No. This device is a physical product and does not involve an algorithm.

• The type of ground truth used:

  • The ground truth for the performance criteria is based on objective, standardized measurements and pass/fail criteria defined by ASTM D5250-92, FDA test methods (e.g., 1000 ml. Water Fill Test, USP Iodine Test), and general biocompatibility testing protocols.

• The sample size for the training set:

  • Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The "training" here would be for the manufacturing process to consistently produce compliant gloves.

• How the ground truth for the training set was established:

  • Not applicable, as there is no "training set" in the AI sense. The manufacturing process is designed and controlled to meet the established performance standards.

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 similar personnel to prevent contamination between and 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 Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient as Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.

The provided document describes the 510(k) summary for the Shijiazhuang Great Eagle Plastic Products Co., Ltd. Synthetic Powder-Free Vinyl Patient Examination Gloves. It details the device, its intended use, comparison to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A 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)

The document does not explicitly state the specific sample sizes for each test conducted. It mentions "samplings of AQL 2.5, Inspection Level S-4" for the Water Fill Test and "Inspection Level S-2, AQL 4.0" for Physical and Dimensions Testing, which are statistical sampling plans but don't provide a direct sample count. The tests were performed on gloves produced by Shijiazhuang Great Eagle Plastic Products Co., Ltd. in Shijiazhuang, He Bei Province, P.R. China. The data would be prospective, as it's generated during the production and testing of new devices.

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)

This section is Not Applicable. The device is a medical glove, and its performance is evaluated against established technical standards (ASTM, FDA water fill, USP iodine test) and biocompatibility tests. These tests have objective criteria and do not rely on expert interpretation to establish "ground truth" in the way a diagnostic imaging device might.

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

This section is Not Applicable. As explained above, the tests performed on the gloves are objective and rely on direct measurements and observations against predefined pass/fail criteria, not on subjective expert consensus 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 section is Not Applicable. The device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant.

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

This section is Not Applicable. The device is a physical medical glove and does not involve any algorithms or AI for standalone performance evaluation.

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

The "ground truth" for the device, a medical glove, is defined by objective, measurable compliance with established international and regulatory standards and test methods:

• ASTM Standard D5250-92: This standard defines physical properties and dimensions for vinyl examination gloves. The "ground truth" is whether the glove's measured properties (e.g., tensile strength, elongation, dimensions) fall within the specified ranges.
• FDA 1000 ml. Water Fill Test: This test determines the watertight integrity (pinhole defects) of the gloves. The "ground truth" is a pass/fail outcome based on whether water leaks through the glove under specific conditions.
• Primary Skin Irritation and Skin Sensitization Testing: These are biological tests conducted to assess the biocompatibility of the glove material. The "ground truth" is the absence of observed irritation or sensitization reactions in test subjects/models.
• USP Iodine Test for Starch: This test objectively determines the presence or absence of starch, which is critical for a "powder-free" claim. The "ground truth" is a passing result indicating minimal or no starch.

8. The sample size for the training set

This section is Not Applicable. The device is a medical glove, not a machine learning model. Therefore, there is no "training set" in the context of AI. The described tests are for product verification and validation.

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

This section is Not Applicable. As stated above, there is no training set for this type of device.

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