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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 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 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 D5250-92.

Here's a breakdown of the acceptance criteria and study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., Physical and Dimensions, Water Fill, Biocompatibility). It mentions:

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0
• FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4

The data provenance is implied to be from Shijiazhuang Hongxiang Plastics Products Co., Ltd. in P.R. China, based on their testing of their own product. The studies appear to be retrospective in the sense that they were conducted on already manufactured products to ensure compliance.

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

This information is Not Applicable to this submission. The device is a patient examination glove, and the "ground truth" for its performance is established through standardized physical, chemical, and biological tests, not through expert interpretation of data like in medical imaging.

4. Adjudication Method for the Test Set

This information is Not Applicable as the ground truth is established through objective, standardized tests, not through subjective human interpretation requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the performance of human readers with and without AI assistance, typically in diagnostic tasks. This device is a medical glove, which doesn't involve diagnostic reading.

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

This information is Not Applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The ground truth used for assessing this device's performance is based on standardized test specifications (ASTM D5250-92 and FDA Water Fill Test requirements) and biological test results (primary skin irritation and skin sensitization).

8. The Sample Size for the Training Set

This information is Not Applicable. There is no "training set" in the context of this device. The manufacturer produces a product and tests it against established standards. This is not an AI/machine learning model that requires training data.

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

This information is Not Applicable for the reasons stated in point 8.

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.

This document describes the acceptance criteria and study proving the device meets those criteria, specifically for Shijiazhuang Dilly Plastics Products Co., Ltd. Synthetic Powdered Vinyl Patient Examination Gloves.

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 specific number of gloves tested is not provided, but these AQL levels dictate the sampling plan. Data provenance is not explicitly stated beyond being conducted by the manufacturer, Shijiazhuang Dilly Plastics Products Co., Ltd.
• FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. The specific number of gloves tested is not provided, but these AQL levels dictate the sampling plan. Data provenance is not explicitly stated beyond being conducted by the manufacturer.
• Primary Skin Irritation and Skin Sensitization: The document does not specify the sample size (e.g., number of subjects, number of tests) for these biocompatibility tests, nor does it explicitly state the country of origin or whether the studies were retrospective or prospective.

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

• Not Applicable. This document pertains to the 510(k) submission for patient examination gloves, which does not involve subjective diagnostic interpretations requiring expert consensus for ground truth establishment. The "ground truth" for these tests (e.g., pinhole presence, skin irritation) is based on objective measurements and established protocols.

4. Adjudication method for the test set:

• Not Applicable. As the device is examination gloves and the tests are objective physical and chemical assessments, there is no need for an adjudication method in the context of expert review or consensus, such as 2+1 or 3+1.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC comparative effectiveness study is not applicable for this type of device (patient examination gloves). These studies are typically used for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is evaluated.

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

• Not Applicable. This device is patient examination gloves, not an algorithm or AI system. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The type of ground truth used:

• The "ground truth" for the tests performed is based on:
  • Objective measurements against established standards: For physical and dimensional properties, the ground truth is whether the glove meets the specifications of ASTM-D-5250-92.
  • Objective experimental outcomes: For the pinhole test, the ground truth is whether water penetrates the glove under specified conditions. For biocompatibility, the ground truth is the presence or absence of a measurable irritating or sensitizing reaction.

8. The sample size for the training set:

• Not Applicable. This documentation is for a physical medical device (examination gloves), not an AI/ML algorithm that requires a training set. The tests performed are quality control and performance verification tests for manufactured products.

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

• Not Applicable. As there is no AI/ML algorithm or training set involved, the concept of establishing ground truth for a training set does not apply.

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 21 CFR 880.6250, Powdered Vinyl Patient Class I, as Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

The provided text is for a 510(k) summary for medical gloves, which are low-risk devices and do not typically involve the types of studies and acceptance criteria that are relevant to AI/ML-powered medical devices. Therefore, much of the requested information, such as multi-reader multi-case studies, standalone algorithm performance, and expert ground truth establishment, is not applicable.

Here's the information that can be extracted or deduced from the provided document, formatted to best fit the request for an AI/ML device, with explanations where the information is not directly applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies "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. These are statistical sampling plans from ASTM standards, not a fixed sample size in the context of typical AI/ML test sets. The exact number of gloves tested for each lot would depend on the size of the manufacturing lot.

Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in China. The data is from non-clinical testing performed by the manufacturer to demonstrate compliance with standards. It is implicitly retrospective in the sense that the tests were performed on manufactured batches.

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

Not applicable. The ground truth for medical gloves is established by objective physical and chemical tests (e.g., water leak tests, measurements of dimensions, chemical assays for irritation). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of images or data to establish ground truth in diagnostic studies. For glove testing, the results are typically quantitative measurements or pass/fail criteria against established standards.

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 medical glove, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical product and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective measurement against established industry and regulatory standards. Specifically:

• Physical and Dimensional Characteristics: Defined by ASTM-D-5250-92.
• Barrier Integrity (Pinhole): Defined by FDA 1000 ml. Water Fill Test (referencing CFR 21 pinhole references) and ASTM-D-5250-92.
• Biocompatibility: Established through Primary Skin Irritation and Skin Sensitization testing, performed to determine the absence of adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML model that requires a training set. The "training" for glove manufacturing would involve process control and quality assurance to meet the specified standards across all production.

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

Not applicable. As there is no AI/ML training set, there is no ground truth to be established in this context. The "ground truth" equivalent for manufacturing is the adherence to the ASTM-D-5250-92 standard and internal quality specifications during the production process.

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