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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.

This looks like a 510(k) premarket notification for disposable vinyl examination gloves, not an AI/ML medical device. Therefore, the questions about AI/ML specific criteria, study design, and performance metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable.

However, I can extract the acceptance criteria and the "study" (non-clinical tests in this context) that proves the device meets them, based on the provided text.

Here's an interpretation based on the document:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

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

• Pinhole Testing (FDA 1000 ml Water Fill Test): "samplings of AQL 2.5, inspection level I". This indicates a specific sampling plan from an Acceptable Quality Level (AQL) standard, but the exact number of gloves tested is not explicitly stated.
• Physical and Dimensional Testing (ASTM-D-5250-00E4): "Inspection level S-2, AOL 4.0". Similar to above, this references an AQL sampling plan, but the exact sample size is not numerically provided.
• Residual Powder Test (ASTM D-6124-06): Not explicitly stated, but implies routine inspection.
• Biocompatibility (Primary Skin Irritation and Skin Sensitization): The exact number of subjects or samples used in these tests is not specified in the document.
• Data Provenance: The device is manufactured by "Super Safe Plastic Products Co., Ltd." in "Shijiazhuang, Hebei, China". The testing was performed by the manufacturer or a contracted lab to demonstrate compliance with US standards. The data is retrospective in the sense that the tests were completed before submission.

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

• This is not applicable as this is a physical medical device (gloves), not an AI/ML diagnostic or interpretive device. The "ground truth" is established through standardized physical, chemical, and biological tests.

4. Adjudication method for the test set:

• Not applicable for this type of device. Compliance is determined by objective measurements 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 as this is not an AI/ML device.

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

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

7. The type of ground truth used:

• The ground truth is based on objective measurements and standardized test methods as defined by ASTM standards (D-5250-00E4, D-6124-06) and FDA test protocols (1000 ml Water Fill Test), as well as biocompatibility testing standards. For example, for the "powder-free" claim, the ground truth is "no more than 2 mg powder per glove" as measured by the ASTM D-6124-06 method.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no "training set" in the context of manufacturing and quality control for gloves; rather, there are manufacturing processes that are controlled to meet specifications.

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

• Not applicable as this is not an AI/ML 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, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00€4.

The provided text describes a 510(k) submission for powdered vinyl patient examination gloves. As such, it is not a study about a software-based AI/ML driven medical device, and therefore the requested information regarding acceptance criteria and studies tailored to such devices is largely inapplicable.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (gloves). The typical performance metrics, study designs (e.g., MRMC, standalone), and ground truth establishment methods for AI/ML devices are not relevant here.

However, I can extract the information that is provided and explain why other requested details are not present.

Inapplicability Note:

The provided text describes the regulatory filing for a physical medical device (powdered vinyl patient examination gloves) and not a software-based AI/ML device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable to this type of device and are not detailed in the provided 510(k) summary. The "acceptance criteria" here refer to conformance with established standards for physical properties and safety, not statistical performance metrics of an algorithm.

Extracted Information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set:
  • Physical and Dimensions: Inspection Level S-2, AQL 4.0 (specific sample size from lot not provided, but these are standard sampling plans).
  • Pinhole/Water Fill Test: AQL 2.5, Inspection level I (specific sample size from lot not provided, but these are standard sampling plans).
  • Biocompatibility: Not explicitly stated how many subjects/samples were used, but standard tests were conducted.
  • Residual Powder: Not explicitly stated how many samples were used, but conducted at finished inspection.
• Data Provenance: Not explicitly stated, implied to be laboratory testing conducted by or for Super Safe Plastic Products Co., Ltd. (China). Retrospective for the purposes of this submission, as the tests were performed prior to submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• Not Applicable. For a physical device like examination gloves, "ground truth" as understood in AI/ML performance studies does not apply. Performance is assessed against established physical and chemical standards and biocompatibility tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) in AI/ML studies. Here, compliance is determined by objective measurements and standardized tests against predefined criteria.

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

• Not Applicable. This type of study is for evaluating AI assistance to human readers, which is not relevant for a physical examination glove.

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

• Not Applicable. This device is not an algorithm. Performance is inherent to the physical product and its manufacturing process.

7. Type of Ground Truth Used

• Established Standards/Objective Measurements: For aspects like physical dimensions, pinhole defects, residual powder, the "ground truth" is adherence to predefined specifications within recognized industry standards (ASTM D-5250-00E4, ASTM D-6124-06) and regulatory requirements (FDA Water Fill Test). For biocompatibility, it's the observed biological response to the product in standard tests.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set." The manufacturing process involves continuous quality control and testing against established product specifications.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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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 A patient 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.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Powder Free Vinyl Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: For the ASTM D-5250-00E4 physical and dimensions testing, the inspection level was S-2, AQL 4.0. For the FDA 1000 ml. Water Fill Test, the inspection level was I, AQL 2.5. The exact number of units sampled for each test is not explicitly stated, but these AQL (Acceptable Quality Level) values dictate the sampling plan.
• Data Provenance: The testing was conducted by Super Safe Plastic Products Co., Ltd. in China. The data is retrospective, as it describes tests performed on the manufactured gloves.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this type of device. The ground truth for performance of examination gloves is established through standardized physical, chemical, and biological tests, not through expert human interpretation or consensus.

4. Adjudication Method for the Test Set

This is not applicable as the performance is measured purely through objective, standardized tests, not subjective interpretations requiring adjudication.

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

This is not applicable. This type of study is used for diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a patient examination glove.

6. Standalone (Algorithm Only) Performance Study

This is not applicable. This device does not involve an algorithm or software. Its performance is determined by its physical and material properties.

7. Type of Ground Truth Used

The ground truth used for this device's acceptance is based on:

• Standardized Test Methods and Criteria: Specifically, ASTM D-5250-00E4 and ASTM D-6124-06 for physical properties and residual powder, and FDA requirements for water fill/pinholes, skin irritation, and sensitization. These standards define the objective measures for performance.

8. Sample Size for the Training Set

This is not applicable. This device does not use machine learning or algorithms, so there is no "training set."

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

This is not applicable for the same reason as above; there is no training set.

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

This 510(k) submission describes the Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, White. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., details on training set, experts, MRMC studies) are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text:

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. The specific sample size for a given lot is not provided but would be determined by the AQL (Acceptable Quality Limit) and inspection level. This is a factory quality control measure, so the data provenance is from the manufacturer's internal testing in China (Shijiazhuang, Hebei, China). This is retrospective testing of manufactured products.
• Pinhole / Water Fill Test: Samplings of AQL 2.5, inspection level I. Similar to above, the specific sample size for a given lot is not provided. Data provenance is from the manufacturer's internal testing in China, retrospective.
• Primary Skin Irritation and Skin Sensitization: The document states that testing was conducted but does not specify the sample size or the data provenance beyond "with results showing." It is typically done on human subjects or animal models as per relevant ISO standards.
• Residual Powder Test: Not specified beyond "at finished inspection."

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 Class I medical device (patient examination gloves) and the testing described is primarily for engineering performance and biocompatibility, not for diagnostic or therapeutic efficacy requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established standards (ASTM, FDA) for physical properties, chemical residue, and biological reactivity, not subjective interpretations 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 barrier (glove), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Physical and Dimensions Testing: The ground truth is defined by the specifications in ASTM D-5250-00E4.
• Pinhole / Water Leak Test: The ground truth is defined by the FDA 1000 ml. Water Fill Test requirements.
• Primary Skin Irritation and Skin Sensitization: The ground truth is established by standard toxicological assessment protocols, typically involving expert interpretation of skin reactions.
• Residual Powder Test: The ground truth is defined by the maximum allowable powder content (2 mg/glove) as per ASTM D6124-06.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable.

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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 containation 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 21 C requirements of ASTM standard D-5250-00E4.

This document describes the 510(k) summary for Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, White. The summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides the following information:

• ASTM D-5250-00E4 (Physical & Dimensions): "Inspection level S-2, AQL 4.0." This refers to sampling plans defined within the ASTM standard. The specific sample size is not explicitly stated in the provided text but would be determined by these parameters.
• FDA 1000 ml Water Fill Test (Pinhole): "Samplings of AQL 2.5, inspection level I." Similar to the above, this indicates the sampling plan, but the exact numerical sample size is not presented.
• Primary Skin Irritation and Skin Sensitization: The document doesn't specify sample sizes for these tests.
• Residual Powder Test: The document doesn't specify sample size for this test.

Data Provenance: Not explicitly stated, but based on the manufacturer's location (Shijiazhuang, Hebei, China), the testing was likely conducted in China. The document does not specify if the data is retrospective or prospective.

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

Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, water fill tests, chemical tests, biocompatibility tests). They do not involve expert interpretation or ground truth establishment in the way, for example, a diagnostic imaging study would.

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective and do not require expert 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 is a medical device for personal protection (gloves), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its evaluation.

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 AI system.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Established ASTM Standards: For physical properties, dimensions, and residual powder content. These standards define objective criteria and test methods.
• FDA Requirements: For the pinhole test (1000 ml Water Fill Test).
• Biocompatibility Testing Protocols: For primary skin irritation and skin sensitization, which involve established biological assessment methods.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model and does not involve a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of non-clinical tests conducted on the Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves, White. These tests were designed to demonstrate compliance with recognized industry standards and regulatory requirements for patient examination gloves.

The key aspects of this study include:

• Compliance with ASTM D-5250-00E4: The gloves were tested for physical and dimensional characteristics, with all results meeting the requirements of this ASTM standard. The sampling plan for these tests was based on "Inspection level S-2, AQL 4.0."
• Pinhole Integrity (FDA 1000 ml Water Fill Test): The gloves underwent the FDA 1000 ml Water Fill Test, meeting the requirements with a sampling plan of "AQL 2.5, inspection level I."
• Biocompatibility Testing:
  • Primary Skin Irritation: Tests were conducted, showing no primary skin irritant reactions.
  • Skin Sensitization (Allergic Contact Dermatitis): Tests were conducted, showing no sensitization reactions.
• Residual Powder Content: A Residual Powder Test based on ASTM D-6124-06 was performed to ensure the gloves meet the "powdered" claim, meaning they contain no more than 10mg/dm2 of starch.

The conclusions of these tests collectively demonstrated that the device "conform[s] fully to ASTM D-5250-00E4 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims." The results provided the basis for the FDA's determination of substantial equivalence to the predicate 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, 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 study for the Powdered Vinyl Patient Examination Gloves:

This document is a 510(k) premarket notification for a Class I medical device (Powdered Vinyl Patient Examination Gloves). For such devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally based on adherence to recognized standards and non-clinical testing rather than complex clinical studies with human participants. The focus is on demonstrating substantial equivalence to a predicate device and meeting established performance specifications.

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 number of gloves tested is not specified but is determined by the AQL (Acceptable Quality Limit) standard for lot inspection.

• FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, inspection level I. The exact number of gloves tested is not specified, but indicated by the AQL standard.

• Primary Skin Irritation and Skin Sensitization Testing: The sample size for these tests (e.g., number of animals or human volunteers if applicable) is not specified in the document.

• Residual Powder Test: Not explicitly stated, but performed at "finished inspection" based on ASTM D-6124-06.

• Data Provenance: The document does not explicitly state the country of origin of the data (e.g., where the independent labs for skin testing were located). However, the manufacturing company is "Super Safe Plastic Products Co., Ltd." located in Shijiazhuang, Hebei, China. The testing would likely have been conducted in China or by labs contracted by the Chinese manufacturer.

• Retrospective or Prospective: These tests are prospective in nature, conducted specifically to demonstrate compliance for this device prior to submission.

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

• Not Applicable in the traditional sense for this device. For Class I general-use products like examination gloves, "ground truth" is established by adherence to recognized consensus standards (like ASTM standards) and regulatory requirements (like FDA water fill tests).
• The tests are objective measurements against established thresholds, rather than subjective expert consensus on complex findings. For the skin irritation/sensitization tests, these would typically be conducted by qualified toxicologists or dermatologists, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

• Not Applicable in this context. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where multiple experts review cases to establish a "ground truth" for diagnostic or prognostic endpoints.
• For these gloves, the "ground truth" is compliance with objective, quantifiable thresholds defined by ASTM standards and FDA test methods. The tests themselves are the "adjudicators" against a set standard.

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

• No. An MRMC study is not relevant or required for a Class I patient examination glove. These studies are typically used to assess the impact of a diagnostic AI algorithm on human reader performance, which does not apply here.

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

• Not Applicable. This device is a physical product (gloves), not an AI algorithm. Therefore, "standalone algorithm performance" is not a concept that applies.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Industry Consensus Standards: Primarily ASTM D-5250-00E4 for physical and dimensional properties, and ASTM D-6124-06 for residual powder.
• Regulatory Requirements: FDA's 1000 ml Water Fill Test for pinholes.
• Biological Compatibility Testing Guidelines: Standard methods for assessing primary skin irritation and skin sensitization.

These act as the objective benchmarks against which the device's performance is measured.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware 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 applicable.

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