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This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

SMARTTEX Pre Powdered Latex Examination Glove Natural. IIE E (AREEN

The provided FDA 510(k) clearance letter (K981348) for "Smarttex PrePowdered Latex Examination Gloves"does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) or machine learning (ML) algorithms.

This clearance is for a class I medical device (latex examination gloves), which are typically subject to general controls and a substantial equivalence review. For such devices, the FDA primarily evaluates whether the device is as safe and effective as a legally marketed predicate device. This usually involves demonstrating equivalence through performance testing related to barrier integrity (e.g., pinhole tests), physical properties (e.g., tensile strength, elongation), and biocompatibility, rather than clinical studies with ground truth established by experts or AI performance metrics.

Therefore, I cannot answer your specific questions about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study with AI.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is a regulatory clearance letter for a physical medical device (gloves) and does not concern an AI/ML-driven device.

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