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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 D5250-00.

The provided text describes the 510(k) summary for Shijiazhuang Eversharp Plastics Products Co., Ltd.'s Synthetic (White) Vinyl Patient Examination Gloves-Powder Free.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating substantial equivalence to a predicate device and adherence to established industry standards.

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

The document does not explicitly state the exact sample sizes used for each specific test (e.g., number of gloves for physical testing, number of subjects for biocompatibility). However, it mentions:

• Physical and Dimensions Testing: The inspection level and AQL (Acceptable Quality Level) values are provided: "Inspection Level S-2, AQL 4.0." These are statistical sampling plans where a certain number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. While not an explicit sample size, they define the statistical rigor of the sampling.
• FDA 1000 ml. Water Fill Test: "AQL 2.5, Inspection Level I." Similar to the above, this indicates a statistical sampling plan.
• Biocompatibility Testing (Primary Skin Irritation and Skin Sensitization): The specific number of subjects or samples is not provided, but the tests were "conducted with results showing no primary skin irritant or sensitization reactions."

Data Provenance: The document implies the data was generated internally by Shijiazhuang Eversharp Plastics Products Co., Ltd. for their product. There is no mention of country of origin of the data beyond the manufacturer's location (China). The studies are inherently prospective as they are tests performed on the device to prove its compliance with standards and claims for premarket notification.

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

The document does not provide information regarding the number or qualifications of experts used to establish the ground truth for the test set. The tests performed (physical, water fill, biocompatibility, residual powder) are typically standardized laboratory tests, where "ground truth" is established by adherence to the specified test methodology and objective measurements, rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements (e.g., physical dimensions, water leakage, chemical residues, biological responses in animal models or in-vitro tests for irritation/sensitization). There is no "adjudication" in the sense of multiple human readers or experts reviewing the same data and reaching a consensus. The results are quantitative or qualitative assessments based on predefined criteria in the standards.

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

Not applicable. This is a medical device for patient examination gloves. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret images or data, and the study assesses the impact of AI assistance on their diagnostic performance. This device is not an imaging or diagnostic AI product, so an MRMC study is not relevant.

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

Not applicable. This device is a physical product (gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The performance metrics are related to the physical and chemical properties of the gloves themselves.

7. Type of Ground Truth Used

The "ground truth" used for these tests is based on:

• Industry Standards: Specifically ASTM Standard D5250-00, which defines the expected physical properties and performance characteristics of synthetic vinyl patient examination gloves.
• Regulatory Requirements: FDA requirements for pinhole/barrier integrity (Water Fill Test) and biocompatibility.
• Manufacturer's Claims: The claim of "powder-free" is verified against a specific standard (ASTM D6124-01).

These are objective, quantitative, or qualitatively verifiable standards and protocols.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device (gloves), not an AI/ML algorithm. There is no "training set" in the context of machine learning. The manufacturing process is controlled to produce gloves that consistently meet the required specifications.

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

Not applicable, for the same reasons as #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 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 D5250-00.

This 510(k) summary is for a medical device (Powdered Synthetic (Yellow) Vinyl Patient Examination Gloves) and does not describe AI/ML software. Therefore, many of the requested fields are not applicable.

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)

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific sample size not provided, but these are standard sampling plans).
• Water Fill Test: Samplings of AQL 2.5, Inspection Level I. (Specific sample size not provided, but these are standard sampling plans).
• Biocompatibility Testing: Not specified whether samples were prospective or retrospective. No explicit country of origin provided for the test data, but the manufacturer is in China.

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), and ground truth is established through standardized physical, chemical, and biological tests rather than expert interpretation of medical images or data.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessments, not for objective standardized testing of physical product properties.

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 device is a patient examination glove and does not involve AI or human reader assistance.

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

Not applicable. This device is a patient examination glove and does not involve an algorithm.

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

The ground truth for the device's performance was established through:

• Adherence to ASTM Standard D5250-00 (for physical and dimensional properties).
• Compliance with FDA 1000 ml. Water Fill Test requirements (for pinhole detection).
• Results from Primary Skin Irritation and Skin Sensitization testing (for biocompatibility).

These are objective, standardized laboratory and biological test results.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device, and therefore no training set or associated ground truth establishment method for a training set is 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 10 ween 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 880.6250, Powdered Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III 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 a 510(k) submission for patient examination gloves, which are low-risk devices. Therefore, the "study" described is primarily a series of non-clinical bench tests and biocompatibility assessments demonstrating equivalence to a predicate device, rather than a clinical trial involving human patients or complex AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: "Inspection Level S-2, AQL 4.0" (The exact sample size isn't explicitly stated but is determined by the AQL and inspection level from ASTM-D-5250-00, which are standard statistical sampling plans.)
• Pinhole Test (FDA 1000 ml. Water Fill Test): "AQL 2.5, Inspection Level I" (Similar to above, sample size is determined by AQL and inspection level from standard testing protocols.)
• Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically performed on a limited number of animal or human subjects/patches under controlled lab conditions.
• Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Eversharp Plastics Products Co., Ltd., in Hebei Province, P.R. China. The data would be prospective as it was generated specifically for this 510(k) submission.

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

Not applicable for this type of device. The "ground truth" for glove performance is established by standardized test methods (ASTM standards, FDA water fill test) and the results are analytical measurements, not subjective interpretations by experts.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined thresholds, not subjective assessments requiring 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

Not applicable. This device is a physical medical product (gloves) and does not involve AI or human readers for diagnostic interpretation.

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

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

7. The Type of Ground Truth Used

The ground truth used for these tests were:

• Standardized Thresholds: Defined by ASTM-D-5250-00 for physical properties and dimensions, and by FDA requirements for the pinhole test.
• Biocompatibility Standards: Established limits and criteria for irritation and sensitization reactions based on recognized testing protocols.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model that requires a "training set."

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

Not applicable. This device is not an AI or machine learning model.

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, 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.

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 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-00.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

This document describes the acceptance criteria and studies conducted for the Shijiazhuang Eversharp Plastics Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves.

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Physical and Dimensions Testing: The sample size is implicitly defined by "Inspection Level S-2, AQL 4.0" as per ASTM-D-5250-00, but a specific number is not provided.
  • Pinhole Test: The sample size is implicitly defined by "AQL 2.5, Inspection Level I" as per the FDA 1000 ml Water Fill Test, but a specific number is not provided.
  • Biocompatibility (Skin Irritation/Sensitization): Not specified.
  • Residual Powder Test: Not specified.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted by the manufacturer, Shijiazhuang Eversharp Plastics Products Co., Ltd., based in Luquan, Hebei Province, P.R. China, implying the data originated from China. The nature of the tests (manufacturing quality control, laboratory testing) suggests they are prospective in nature, performed on the manufactured product.

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

Not applicable. The tests performed are objective, quantitative measurements (e.g., physical dimensions, water fill test, chemical analysis for powder, biological response in irritation tests) rather than subjective assessments requiring expert consensus for ground truth.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established standards, not requiring multi-reader 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

Not applicable. This device is a patient examination glove, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for performance validation is defined by:

• Established ASTM Standards: ASTM-D-5250-00 for physical characteristics and dimensions, and ASTM D6124-97 for residual powder.
• FDA Requirements: Specific FDA requirements for pinhole testing (1000 ml Water Fill Test).
• Biocompatibility Testing Protocols: Standard methods for primary skin irritation and sensitization testing.
  These are all objective, quantitative, and standardized criteria.

8. The sample size for the training set

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

Ask a specific question about this device