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The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) 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.

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I am sorry, but based on the provided document, there is no scientific study or data available to describe the acceptance criteria, device performance, and other related details you requested.

The document is a letter from the FDA to Hartalega Sdn. Bhd. regarding their 510(k) premarket notification for "Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information for marketing the device.

The document does not contain:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes for test sets or data provenance.
• Details on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• The type of ground truth used (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training sets was established.

This document is a regulatory clearance letter, not a scientific study report.

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The Latex Powder Free Examination Glove with Colloidal USP Skin Protectant is a non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant.

The provided text describes a 510(k) premarket notification for "Latex Powder Free Examination Gloves with Colloidal Oatmeal USP Skin Protectant." This document is a regulatory approval letter from the FDA, and it does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device.

The product is a physical medical device (gloves), not a software or AI device. Therefore, the requested information about device performance, ground truth, study design, and AI-specific metrics is not applicable to this document.

To answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. This document is an FDA approval letter for a physical product (gloves), not a performance report for an AI/software device. Acceptance criteria for gloves would typically involve physical properties like tensile strength, freedom from holes, and biocompatibility, which are not detailed here.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no test set for an AI model.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment for a physical glove in the context of an AI model.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

The document primarily states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs as intended and is as safe and effective as existing products. It mentions the "Indications for Use" (prevent contamination between patient and examiner) but does not provide performance metrics or study details.

Ask a specific question about this device

A Latex Powder Free examination glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient

Latex Powder-Free Examination Gloves

This document is a 510(k) clearance letter from the FDA for "Latex Powder-Free Examination Gloves." It is not a study demonstrating the performance of an AI-powered medical device. Therefore, it does not contain the information requested in the prompt.

The document discusses:

• The FDA's review of a premarket notification (510(k)) for examination gloves.
• The determination of substantial equivalence to legally marketed predicate devices.
• The classification of the device (Class I) and applicable regulations.
• The intended use of the gloves ("worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient").

There is no mention of acceptance criteria for an AI device, study results, sample sizes, expert ground truth, MRMC studies, or training sets for AI.

Ask a specific question about this device