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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 Synthetic Examination Gloves with Aloe Vera, Green Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided document describes the acceptance criteria and the study performed for a medical device: Better Care Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color.

Here's 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 Data Provenance

• ASTM D-5250-06e1 Testing: The document states "Inspection level S-2, AQL 4.0" for physical and dimensions testing. AQL (Acceptable Quality Limit) and inspection level are metrics for sampling, but the precise sample size in numbers is not explicitly stated.

• FDA 1000 ml. Water Fill Test: "Samplings of AQL 2.5, inspection level I" were conducted. Again, a precise numerical sample size is not provided, but these metrics define the sampling plan.

• Primary Skin Irritation and Skin Sensitization: The sample size for these tests is not specified in the document.

• Residual Powder Test: The sample size for this test is not specified.

• Data Provenance: The studies were performed by Better Care Plastic Products Co., Ltd. for their product. The location of the company is Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province 050000 (China). The data is retrospective as it was collected before the 510(k) submission.

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

• This information is not applicable as the tests performed are primarily laboratory-based performance and safety tests for examination gloves, not diagnostic studies requiring expert review of medical images or data. Ground truth here refers to the objective results of the specified physical, chemical, and biological tests.

4. Adjudication Method for the Test Set

• This is not applicable. The tests are objective and performed according to established ASTM standards and FDA protocols (e.g., water fill test). There is no "adjudication" in the sense of reconciling differing expert opinions, as the results are determined by the test procedures themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This is not applicable. The device is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

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

• This is not applicable. The device is an examination glove and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

• The ground truth for this device is based on objective measurements and laboratory test results adhering to recognized standards (ASTM D-5250-06e1, ASTM D-6124-06) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility assessments). It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense. It's the inherent physical and chemical properties of the glove.

8. The Sample Size for the Training Set

• This is not applicable. The device is a physical medical product (examination gloves) that undergoes testing based on established standards, not a machine learning model that requires a "training set."

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

• This is not applicable for the same reason as point 8.

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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, (Yellow, white, blue, pink), 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

Here's a breakdown of the acceptance criteria and study information for the Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, based on the provided K092301 510(k) summary:

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 explicitly stated, but it would be determined by the sampling plan outlined in ASTM-D-5250-06e1 for an AQL of 4.0 at an S-2 inspection level.
• Pinhole Detection (Water Fill Test): AQL 2.5, Inspection Level I. The specific number of gloves tested is not explicitly stated, but it would be determined by the sampling plan for an AQL of 2.5 at an Inspection Level I.
• Primary Skin Irritation and Skin Sensitization: The document states "testing was conducted" but does not specify the sample size (e.g., number of subjects or samples) used for these biocompatibility tests.
• Residual Powder Test: Based on ASTM D-6124-06. The number of gloves tested for residual powder is not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the data or if the studies were retrospective or prospective. Given that this is a 510(k) for a manufacturing company, it's likely that the tests were conducted by or on behalf of the manufacturer to demonstrate compliance with standards.

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

This type of device (patient examination gloves) does not typically involve human experts establishing "ground truth" in the way an AI diagnostic device would. The "ground truth" for these tests is established by objective, standardized laboratory measurements and compliance with industry standards (e.g., ASTM standards, AQL limits for defects). There are no "experts" in the sense of clinicians interpreting results for a test set.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory tests with defined pass/fail criteria based on standards. There is no subjective interpretation requiring adjudication among multiple readers.

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

No. An MRMC study is relevant for AI devices that assist human readers in tasks like image interpretation. This device is a physical product (gloves), and its performance is evaluated through material and quality control tests, not through human reader interpretation.

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

Yes, in a sense. The tests performed (physical, dimensions, pinhole, biocompatibility, residual powder) evaluate the intrinsic properties and performance of the glove itself, without any human-in-the-loop or interpretive component in the way an algorithm would be evaluated. The "device" (glove) is tested in a standalone manner against defined physical and chemical parameters.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, standardized measurements and compliance with established industry standards.

• For physical properties and dimensions, the ground truth is defined by the tolerances and specifications within ASTM-D-5250-06e1.
• For pinholes, the ground truth is defined by the FDA 1000 ml. Water Fill Test and its AQL 2.5 acceptance criterion.
• For biocompatibility (skin irritation and sensitization), the ground truth is established by the absence of adverse reactions in standardized biological tests.
• For residual powder, the ground truth is the quantitative measurement of powder content against the 2 mg per glove limit specified by ASTM D-6124-06.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm that requires a 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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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 1, 21 CFR 880.6250, Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided text is a 510(k) summary for a medical device: "Better Care Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color." This document describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested elements for an AI/ML study (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical tests that were performed to demonstrate substantial equivalence to the predicate device.

Here's the information based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size:
  • For physical and dimensions testing: Inspection Level S-2, AQL 4.0. (Specific number not provided, but these are statistical sampling plans.)
  • For FDA 1000 ml. Water Fill Test: Inspection Level G-1, AQL 2.5. (Specific number not provided, but these are statistical sampling plans.)
  • For Primary Skin Irritation and Skin Sensitization: Not specified.
  • For Residual Powder Test: Not specified (but for powder at finished inspection to ensure "powder-free" claims).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are laboratory tests conducted on samples of the manufactured gloves.

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

• This is not applicable to the non-clinical testing of examination gloves. The "ground truth" or acceptance criteria are based on established ASTM standards and FDA requirements, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against physical and chemical standards, not 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 not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for the tests mentioned are the established ASTM standards and FDA requirements for glove performance (e.g., tensile strength, elongation, dimensions, freedom from pinholes, biocompatibility, residual powder limits).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set. The manufacturing process is implicitly "trained" through quality control and adherence to standards, but not in the AI/ML sense.

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

• Not applicable.

Ask a specific question about this device

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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06el.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets those criteria:

Acceptance Criteria and Device Performance for Better Care Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Glove (K092296)

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an equivalency study based on established ASTM standards and FDA requirements rather than defining novel acceptance criteria for a new type of device. The acceptance criteria are therefore the requirements set by the cited standards for this device type.

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

• Physical and Dimensions Testing: "Inspection level S-2, AQL 4.0". The specific numerical sample size is not explicitly stated but is implicitly defined by the AQL (Acceptance Quality Limit) and inspection level (S-2) within Quality Assurance sampling plans, likely based on ANSI/ASQ Z1.4 (or equivalent) tables.
• Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level 1". Similar to above, the specific numerical sample size is not explicitly stated, but defined by AQL and inspection level. This is a common sampling plan for medical gloves.
• Biocompatibility (Primary Skin Irritation and Skin Sensitization): The specific sample size (e.g., number of test subjects or animals) is not provided.
• Residual Powder Test: The specific sample size is not provided, but it's stated to be conducted "at finished inspection."

Data Provenance: The document does not explicitly state the country of origin for the data collection for these tests. However, the submitter is "Better Care Plastic Products Co., Ltd." from "Hebei Province 050000" in China, suggesting the testing was likely conducted in or contracted by the manufacturing company in China, following international standards. The tests are retrospective, performed on manufactured products.

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

This submission describes pre-market testing for a Class I medical device (patient examination glove), which relies on objective performance measurements against established standards, not expert consensus on interpretations of complex data (like image analysis). Therefore, the concept of "experts establishing ground truth for the test set" in the context of, for example, multiple radiologists reviewing images, does not directly apply here.

The "ground truth" for glove performance is defined by the objective metrics and thresholds specified in the ASTM standards (D-5250-06e1, D-6124-06) and FDA test methods (1000 ml. Water Fill Test). The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel who are trained in performing these specific tests and interpreting the results according to the published standards. Their qualifications would involve training in laboratory procedures, statistical quality control, and knowledge of the relevant ASTM and FDA guidelines for medical device testing.

4. Adjudication Method for the Test Set:

Adjudication methods like "2+1" or "3+1" are typically used when there's subjective interpretation involved, such as clinical reads or image analysis, where multiple experts might disagree. In this case, the tests are objective:

• Physical dimensions are measured.
• Pinhole tests are pass/fail based on water leakage.
• Irritation/sensitization tests are based on observed reactions or lack thereof.
• Residual powder is measured quantitatively.

Therefore, a formal "adjudication method" in the sense of reconciling differing expert opinions is not applicable. The results are directly derived from the test protocols. Any potential disputes would arise from re-testing, calibration, or auditing of the testing facility, not from subjective expert disagreement on the outcome of a particular test.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the goal is to assess how a new technology (e.g., AI) impacts human performance. A patient examination glove is a simple physical barrier device, and its safety and effectiveness are assessed through physical, chemical, and biological testing as described, not by human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This is not applicable as the device is a physical product (a glove), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth used for demonstrating compliance is objective performance data derived from standardized laboratory tests and measurements. This includes:

• Physical Measurements: Tensile strength, elongation, dimensions, etc., against ASTM D-5250-06e1 specifications.
• Leakage/Barrier Integrity: Pass/fail rates for the FDA 1000 ml. Water Fill Test.
• Biocompatibility Data: Results from primary skin irritation and skin sensitization tests (e.g., absence of observed reactions).
• Chemical Analysis: Quantitative measurement of residual powder against ASTM D-6124-06 and the "

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