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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 Powder Free Latex Examination Gloves, with protein labeling claim ('50 micrograms or Less) NATURAL, BLUE & GREEN Colored

The provided text is a 510(k) premarket notification letter from the FDA regarding "SMARTTEX Powder Free Latex Examination Gloves, with Protein Content Labeling Claim (50 Micrograms or Less (Natural, Blue and Green Colored))".

This document is a regulatory approval letter for a medical device (examination gloves) and does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as typically found in reports for AI/software-based medical devices.

Instead, the letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and can therefore be marketed. The "Indications for Use" section simply describes the intended purpose of the gloves: "This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

Therefore, I cannot provide the requested information as it is not present in the given text. The questions posed are relevant to the evaluation of AI/software devices, which this product is not.

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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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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 PrePowdered Latex Examination Gloves with Protein claim. (100 MICROGRAM OR LESS) WHITE, BLUE + GREEN

I'm sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for medical gloves and does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily discusses the substantial equivalence of the gloves to previously marketed devices and regulatory compliance.

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