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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.

Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Shandong Intco Medical Products Co., Ltd Latex Examination Gloves, Powder Free.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document provides two tables that fulfill this request:

• A "Technology Characteristic Comparison between the device and predicate device" table on page 4-5.
• A "Non-clinical Testing Summary" table on page 6.

Let's combine and summarize the relevant information from both into a single table for clarity. Note that some "acceptance criteria" are simply the standard reference, and the "reported device performance" indicates "Complied with the standard". For detailed numerical values, refer to the "Technology Characteristic Comparison" table.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for Freedom of Holes, or how many individuals for skin irritation). It only reports the average values or compliance statements.

The data provenance is not explicitly stated as retrospective or prospective for the non-clinical tests. The company, Shandong Intco Medical Products Co, Ltd, is located in China, suggesting the testing likely occurred there or was commissioned by them.

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)

This information is not applicable to the type of device and testing described. The device is a "Latex Examination Glove," and its performance is evaluated through physical, chemical, and biological non-clinical tests based on established international standards (ASTM, ISO). Expert interpretation of medical images or diagnoses is not involved in establishing the "ground truth" for glove performance. The "ground truth" here refers to the measured physical and chemical properties and biological reactions as defined by the standards.

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

Not applicable. As noted above, the testing involves non-clinical measurements against predefined standard specifications, not a subjective interpretation requiring adjudication by multiple experts.

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-assisted diagnostic tool or system that involves human readers.

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

Not applicable. The device is a physical product (medical glove), not an algorithm.

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

The ground truth used for evaluating the Latex Examination Gloves is based on established international and national standards and specifications for medical gloves. This includes:

• ASTM D3578-19 (Standard Specification for Rubber Examination Gloves) for physical properties.
• ASTM D6124-06 (Reapproved 2017) (Standard Test Method for Residual Powder on Medical Gloves) for residual powder.
• ASTM D5151-06 (Reapproved 2015) (Standard Test Method for Detection of Holes in Medical Gloves) for freedom of holes.
• ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) for biocompatibility.

The "ground truth" is therefore the objective measurement of the glove's characteristics against these well-defined and accepted standard limits.

8. The sample size for the training set

Not applicable. The device is a physical medical product, not an AI/ML algorithm that requires a training set. The performance data is from non-clinical testing of the manufactured product.

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 a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Latex Examination Gloves, Powder Free, Polymer Coated

This is an FDA 510(k) clearance letter for "Latex Examination Gloves, Powder Free, Polymer Coated". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.

Here's why the requested information cannot be extracted and what the document does provide:

• No Acceptance Criteria or Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide specific performance metrics (e.g., tensile strength, puncture resistance, barrier integrity) or the acceptance criteria for those metrics. This level of detail would typically be found in the 510(k) submission itself, not the clearance letter.
• No Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): As this is a clearance letter and not a study report, it does not describe any specific studies conducted by the manufacturer to demonstrate performance. The "substantial equivalence" determination relies on demonstrating that the new device is as safe and effective as a predicate device already on the market, often through comparison of materials, design, and intended use, and sometimes through performance testing if there are significant differences from the predicate. However, the details of such testing, if performed, are not in this letter.
• No Information on Experts, Adjudication, or MRMC Studies: These concepts are typically relevant for AI/ML-based diagnostic devices or complex imaging analysis, where expert interpretation and consensus are crucial for establishing ground truth and evaluating human-AI interaction. This document is for a physical medical device (examination gloves), so these types of studies are not applicable or mentioned.
• Standalone Performance: The concept of "standalone performance" (algorithm only) is not relevant to a physical medical device like gloves.

What the document does tell us:

• Device Name: Latex Examination Gloves, Powder Free, Polymer Coated
• Regulation Number & Product Code: 880.6250, LYY (Patient Examination Gloves)
• Regulatory Class: I (lowest risk class, subject to general controls)
• Indications For Use: A disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
• Date of Clearance: June 7, 2002
• Type of Clearance: 510(k) Premarket Notification, based on "substantial equivalence" to a predicate device.

To obtain the detailed information requested, one would need to access the original 510(k) submission (K021412), which is usually publicly available through the FDA's databases, although often redacted for proprietary information. That submission would describe the specific tests performed (e.g., physical property testing, biocompatibility, leak testing) and the criteria used to demonstrate that the gloves meet recognized standards and are substantially equivalent to marketed predicate devices.

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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Natural Latex Examination Gloves with Protein Claim (50mcg or less EXTRACTABLE PROT

This document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves, Powder Free with Protein Labeling Claim, (50 mcg or less)". It does not contain information about the acceptance criteria and study proving device meets the acceptance criteria in the format requested.

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It details general regulatory provisions and contact information for further inquiries.

Therefore, I cannot provide the requested table and study information based on the given input.

Ask a specific question about this device

A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves, Powder Free". It indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

The letter pertains to regulatory clearance and does not include details about:

• Specific acceptance criteria (like performance metrics, accuracy thresholds, etc.)
• A study proving the device meets acceptance criteria (e.g., clinical trial results, performance data)
• Sample sizes for test or training sets
• Data provenance or ground truth establishment
• Details about expert involvement, adjudication, or MRMC studies

Therefore, I cannot fulfill your request based on the provided text.

Ask a specific question about this device