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A patient examination Vinyl Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Vinyl Powder Free Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Vinyl Powder Free Examination Gloves." It primarily concerns regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies of the device itself. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria is not present here.

Based on the provided text, I can answer some of the questions, but many will be marked as "Not Applicable" or "Information Not Provided" because this type of regulatory correspondence does not contain such details.

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

This information is Not Provided in the document. The letter states the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the same performance standards, but it does not specify those standards or the Great Glove (China) Incorporated's device's performance against them.

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

This information is Not Provided. The document does not describe any specific test set or data.
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 as no test set or ground truth establishment is described for a performance study.

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

This information is Not Applicable as no test set or adjudication process is described for a performance study.

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 information is Not Applicable. This device is a Vinyl Powder Free Examination Glove, which is a physical medical device, not an AI-assisted diagnostic tool.

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

This information is Not Applicable. This device is a physical medical device, not an algorithm.

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

This information is Not Applicable as no specific performance study or ground truth establishment is described. The "ground truth" for regulatory approval in this context is the safety and effectiveness profile of the predicate device.

8. The sample size for the training set

This information is Not Applicable as this is a physical medical device, not a machine learning model requiring a training set.

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

This information is Not Applicable as this is a physical medical device, not a machine learning model requiring a training set and associated ground truth establishment.

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

Powdered Vinyl Examination Glove

I apologize, but the provided text from the FDA 510(k) summary for the "Powdered Vinyl Examination Glove" does not contain the kind of detailed information requested about acceptance criteria and a study proving device performance as typically understood for AI/software-as-medical-device (SaMD) products.

This document is a marketing clearance letter for a physical medical device (gloves), not a software or AI product. The 510(k) process for traditional devices like examination gloves primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through physical performance testing rather than clinical study efficacy for a diagnostic or therapeutic purpose.

Therefore, I cannot extract the requested information. The document does not describe:

1. Acceptance criteria and reported device performance in a table: While there are regulations for gloves (e.g., barrier integrity), specific acceptance criteria and performance data in a detailed table as requested for an AI model are not present.
2. Sample size and data provenance for a test set: This is not relevant for a physical glove's 510(k) submission in the context of an AI study.
3. Number/qualifications of experts for ground truth: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is for an AI-assisted diagnostic or therapeutic tool.
6. Standalone performance (algorithm only): Not applicable, as this is not an algorithm.
7. Type of ground truth: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

The document does state the Indications for Use: "A patient examination Vinyl Powdered Gloves is a disposable medical purpose that is worn on the device intended for medical contamination between patient and examiner." This indicates its purpose is as a barrier for medical examinations.

For a medical device like this glove, the "studies" usually involve physical and chemical testing to ensure it meets general controls and performance standards (e.g., tensile strength, resistance to tearing, absence of pinholes, biocompatibility). These details are typically found in the full 510(k) submission, but not in the clearance letter provided.

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