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Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber Intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

Latex Examination Glove, Powder Free Non Sterile is a disposable device and made of Natural Rubber

This document is an FDA 510(k) clearance letter for a medical device: "Senstouch Latex Examination Glove, Powder Free Non Sterile."

Since this is a regulatory clearance for a medical device (a glove), the acceptance criteria and study information typically associated with complex AI/ML algorithms or software are not applicable here.

Medical gloves are cleared based on adherence to recognized standards for performance (like ASTM standards for physical properties, barrier integrity, and biocompatibility). The FDA determines substantial equivalence to a predicate device, meaning it performs as safely and effectively as a legally marketed device.

Here's why each point in your request is not applicable to this document:

1. A table of acceptance criteria and the reported device performance: This document doesn't contain a detailed table of acceptance criteria and performance data. The clearance is based on satisfying general controls and demonstrating substantial equivalence to a predicate, often through adherence to recognized consensus standards.
2. Sample size used for the test set and the data provenance: Not relevant for a glove clearance in this context. Testing would involve physical and chemical properties, not a "test set" of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not relevant. Ground truth in this context would refer to objective physical/chemical measurements against standards, not expert medical opinion on a diagnostic outcome.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not relevant. Adjudication methods are used for interpreting complex medical imaging or clinical data, not for material properties of a glove.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size of how much human readers improve with AI vs without AI assistance: Not relevant. This is for AI-assisted diagnostic tools, not basic medical devices like gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. Again, this applies to AI/ML algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not relevant in the typical sense. "Ground truth" for a glove would be objective measures of its physical integrity, tensile strength, freedom from holes, biocompatibility, etc., as per established material science standards.
8. The sample size for the training set: Not relevant. There is no "training set" for a physical medical device like a glove.
9. How the ground truth for the training set was established: Not relevant.

In summary: This document is an FDA 510(k) clearance letter confirming that the "Senstouch Latex Examination Glove, Powder Free Non Sterile" is substantially equivalent to existing devices. The detailed analytical and clinical study information requested is applicable to AI/ML-driven medical devices, not to a standard medical glove undergoing a 510(k) clearance process described here. The "study" here refers to the testing performed to demonstrate that the glove meets relevant ASTM or ISO standards for medical gloves, and a comparison to a predicate device.

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