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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.

The provided text describes the 510(k) submission for Anhui Intco Medical Products Co. Ltd.'s Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered medical device through a clinical study.

Therefore, most of the requested information regarding AI device acceptance criteria and study details (such as MRMC studies, standalone algorithm performance, AI training/test set ground truth, and expert qualifications for ground truth establishment) is not applicable to this document.

However, I can extract information related to the performance characteristics that were tested for these medical gloves to demonstrate substantial equivalence.

Here's the information that is applicable based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document compares the subject device (K191092) to a predicate device (K022091) across various physical and biocompatibility characteristics. The "acceptance criteria" here are essentially the performance levels of the predicate device or established standards (like ASTM).

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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 fingers to prevent contamination between patient and examiner.

Powder-free Vinyl Patient Examination Gloves, Yellow Color. A disposable device intended for medical purposes that is worn upon the examiner's hands or finger. Prevent contamination between patient and examiner. Cover the hand and wrist area. Covers have separate sheaths or openings for each finger and the thumb.

This document is a 510(k) summary for a medical device: Powder-free Vinyl Patient Examination Gloves, Yellow Color. It focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "device" in this context is the glove itself, not an AI or software-based medical device.

As a result, most of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, data provenance, number/qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established) is not applicable to this type of medical device filing.

However, I can extract the acceptance criteria and reported performance for the physical characteristics of the gloves based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Confirmed with ASTM D5250-06" or "Meet ASTM D5250-06" for physical properties and "Meet ASTM D6124-06" for residual powder. For biocompatibility, the criteria are "Not a sensitizer" and "Not an irritant." The reported device performance indicates that the proposed device meets these standards.

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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.

Classified by FDA's General and Plastic Surgery Device panel as Class I, and meets all requirement of ASTM Standard D5250-06. The subject device is a garment covering the hand and wrist area. Clovers have separate sheaths or openings for each finger and the thumb. And vinyl films form a barrier to body fluid and blood-borne pathogens, and that the vinyl rubber is water tight under normal conditions of use. Its tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.

The acceptance criteria and device performance information from the provided text are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size:
  • For Pinhole Results (ASTM D5151-06): At least 125 pieces of gloves were tested.
  • For Water Fill Test: Specific sample size not explicitly stated, but performed with "samplings of AQL 2.5, Inspection Level I."
  • For Physical and Dimensions Testing: "Inspection Level S-2, AQL 2.5" was used, which implies a sample size determined by these AQL standards, but the exact number isn't quantified.
• Data Provenance: The document does not specify the country of origin of the data for these tests. It implies these were internal tests conducted by the manufacturer, Shandong Yifan Plastic Products Co., Ltd., based in Zibo City, Shandong, China. The tests are presented as being conducted to demonstrate substantial equivalence, suggesting they were prospective tests performed on the device prior to submission.

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

This device (patient examination gloves) is a Class I medical device and typically does not involve human expert interpretation for establishing the "ground truth" in the same way an AI diagnostic device would. The "ground truth" is established by direct physical measurements and standardized chemical/biological tests. Therefore, this section is not applicable in the context of this device and report. The tests performed are objective, measurable physical properties and biocompatibility assessments.

4. Adjudication Method for the Test Set:

Not applicable. The tests are objective measurements (e.g., tensile strength, dimensions, pinhole count, chemical content) or standard biological assays (e.g., skin irritation, sensitization) that result in direct numerical or categorical outcomes, not requiring expert adjudication of subjective interpretations.

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 an AI would assist or replace them. For patient examination gloves, such a study is not applicable.

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 algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for this device is established through:

• Objective Physical Measurements: Tensile strength, ultimate elongations, overall length, width, palm thickness, finger thickness, residual powder, and water leak test. These are directly measurable properties.
• Standardized Biological Tests: Primary skin irritation and dermal sensitization. These produce objective results (e.g., "not an irritant," "not a sensitizer") based on established protocols.
• Conformance to Standards: The "ground truth" is implicitly defined by the requirements outlined in the referenced ASTM standards (ASTM D5250-06, ASTM D6124-06, ASTM D5151-06) and the FDA 1000 ml. Water Fill Test.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI development. It is a manufactured physical product.

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

Not applicable, as there is no training set for this device.

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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.

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 D5250-06.

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

Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color

1. Table of Acceptance Criteria and Reported Device Performance

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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 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)

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 requirement of ASTM Standard D5250-06.

The provided text describes a 510(k) summary for "Shandong Zhiyuan Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free, Yellow Color". This document is for a medical device (examination gloves) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-powered diagnostic device from the perspective of an acceptance criteria table.

Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable to this type of device submission. The submission is primarily based on meeting established physical and biological standards for examination gloves.

Here's an analysis of the provided information within the context of the prompt, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a single "test set" sample size. The document refers to "samplings" for the FDA 1000 ml Water Fill Test and for physical/dimensions testing, indicating that batches of gloves were tested according to AQL (Acceptable Quality Level) standards. AQL 2.5 usually implies a sampling plan where a certain number of gloves are inspected from each lot based on lot size, and if the number of defects exceeds a pre-defined limit, the lot is rejected.
• Data Provenance: The testing was conducted by Shandong Zhiyuan Medical Products Co., Ltd. (China). The data is retrospective in the sense that it was collected from manufactured gloves for the purpose of the 510(k) submission.

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

• Not Applicable: This product is a physical medical device (gloves), not an AI-powered diagnostic tool requiring expert ground truth for image or data interpretation. The "ground truth" is based on objective physical, chemical, and biological test results as per established standards and protocols.

4. Adjudication Method

• Not Applicable: There is no "adjudication method" in the context of expert review for diagnostic output. The tests (e.g., water fill, skin irritation) have defined pass/fail criteria.

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

• Not Applicable: This is not an AI-powered diagnostic device where human reader improvement with AI assistance would be relevant.

6. Standalone Performance

• Not Applicable: Standalone performance, in the context of an AI algorithm operating without human intervention, is not applicable to an examination glove. The performance evaluation here is about the device itself meeting physical and biological specifications.

7. Type of Ground Truth Used

• Objective Test Results and Standards Conformance: The "ground truth" for this device's performance is established by:
  • ASTM Standard D5250-06: A consensus standard for vinyl patient examination gloves.
  • FDA 1000 ml Water Fill Test: A standardized test for pinhole defects.
  • Biocompatibility Testing Protocols: Standardized tests for primary skin irritation and sensitization.
  • Gravimetric Analysis: To determine powder content.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" in the AI/machine learning sense for this device. The manufacturing process of gloves does not involve training an algorithm from data.

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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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 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)

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 requirement of ASTM Standard D5250-06.

The provided document describes the acceptance criteria and the study conducted for Shandong Zhanpeng Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free, Yellow Color.

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, AOL 2.5 (Specific sample size not provided, but these are statistical sampling plans). Data provenance is from testing conducted by the manufacturer, presumably in China.
• FDA 1000 ml. Water Fill Test: Samplings of AOL 2.5, Inspection Level I (Specific sample size not provided, but these are statistical sampling plans). Data provenance is from testing conducted by the manufacturer, presumably in China.
• Primary Skin Irritation and Skin Sensitization Testing: Sample size is not specified. Data provenance is from testing conducted by the manufacturer.

The data is retrospective as it was collected as part of the 510(k) submission process to demonstrate substantial equivalence to a predicate device.

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 the device is a medical glove, and the "ground truth" is established through standardized laboratory tests (e.g., ASTM standards, FDA water fill test, biocompatibility tests) rather than expert interpretation of images or clinical data.

4. Adjudication method for the test set:

Not applicable for this type of device and testing. The evaluation of test results is based on meeting predefined specifications of the ASTM standard and FDA requirements.

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; it 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 a medical glove; it does not involve an algorithm.

7. The type of ground truth used:

The ground truth is based on the results of standardized laboratory testing as per ASTM-D-5250-06 and the FDA 1000 ml Water Fill Test, as well as biocompatibility testing. This is objective data derived from physical and chemical properties and biological responses, not expert consensus or pathology in the context of diagnostic imaging.

8. The sample size for the training set:

Not applicable. This device is a medical glove, and its performance is established through direct physical, dimensional, and biocompatibility testing, not through machine learning models requiring training data.

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

Not applicable for the reasons stated above.

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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 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)

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 requirement of ASTM Standard D5250-06.

The provided text describes the 510(k) summary for the "Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free, Yellow Color."

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:

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

• Sample Size: The document mentions "samplings of AQL 2.5" and "Inspection Level S-2, AOL 2.5" for various tests. These are Acceptable Quality Limit (AQL) levels and Inspection Levels specified in quality control standards (like ASTM). While they define the statistical sampling plan (how many gloves are inspected from a lot and how many defects are allowed), they do not explicitly state the total number of gloves (sample size) actually tested for each criterion. The general practice for such tests involves taking samples from production lots.
• Data Provenance: The tests were conducted internally by Zibo Yingbo Medical Products Co., Ltd. or contracted labs on their behalf, adhering to established standards (ASTM, FDA). The provenance is specific to the manufacturer's testing of their product. No external country of origin or retrospective/prospective nature of data is mentioned beyond the manufacturing location (China) and the date the summary was prepared (Feb. 10, 2010), indicating the tests pre-date this submission.

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

This information is not applicable to this type of device. Patient examination gloves are class I devices where performance is measured through objective physical, chemical, and biological tests based on recognized standards, not subjective expert interpretation of images or patient data. The "ground truth" is defined by passing the specified thresholds in ASTM and FDA test methods.

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

This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation by multiple human readers (e.g., radiologists) is involved in determining a "ground truth" for a diagnostic algorithm. For gloves, tests are objective and follow defined protocols, so no multi-reader adjudication is necessary.

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 is not applicable. The device is a physical product (patient examination gloves), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

This is not applicable. This device is a glove, not an algorithm.

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

The "ground truth" for these gloves is established by:

• Standard Specifications: Meeting predefined physical properties (e.g., tensile strength, elongation), dimensional tolerances, and leakage resistance as outlined in ASTM D5250-06.
• Biocompatibility Standards: Demonstrating the absence of significant irritation or sensitization through specific biological tests, where "ground truth" is defined by the absence of a reaction according to test protocols.
• Chemical Analysis: Confirming the "powder-free" claim through quantitative measurement of powder content (e.g., less than 2 mg per glove).

These are all objective, measurable criteria defined by established industry and regulatory standards.

8. The sample size for the training set:

This is not applicable. This is a product that undergoes manufacturing and quality control testing, not an AI model that requires a "training set."

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

This is not applicable. There is no "training set" for this type of device.

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