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A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

The provided text is a 510(k) premarket notification letter from the FDA to Kanam Latex Industries PVT. Limited for "Powder Free Latex Sterile Patient Examination Gloves." The document confirms substantial equivalence but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in detailed performance reports for more complex medical devices.

The device in question, "Powder Free Latex Sterile Patient Examination Gloves," is a Class I medical device. For such devices, the FDA typically assesses substantial equivalence primarily based on comparison to a legally marketed predicate device rather than requiring extensive clinical studies with specific performance metrics and acceptance criteria in the same way as, for example, an AI diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not present in this type of FDA document for this specific device.

Here's the breakdown of why the information is not present and what can be inferred:

1. A table of acceptance criteria and the reported device performance: Not provided. For gloves, acceptance criteria usually relate to physical properties (tensile strength, elongation, barrier integrity, sterility), absence of powders, and biocompatibility. These are typically tested against recognized consensus standards (e.g., ASTM standards) rather than clinical performance metrics in a study report summarized in a 510(k) letter. The letter states the device is "substantially equivalent" to predicate devices, implying it meets similar performance and safety standards.

2. Sample sized used for the test set and the data provenance: Not provided. Performance testing for gloves would involve laboratory testing of physical and chemical properties from a sample of gloves. The letter does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on images) is not relevant for examination gloves. Performance is assessed through standardized laboratory tests.

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. This is for AI-assisted diagnostic devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI or software-as-a-medical-device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance. For gloves, "ground truth" would be the objective measurements from laboratory tests (e.g., burst pressure, freedom from holes, protein content).

8. The sample size for the training set: Not applicable. This device does not involve AI or machine learning that requires a training set.

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

Summary based on the provided document:

The FDA letter confirms that the "Powder Free Latex Sterile Patient Examination Gloves" (K052728) are substantially equivalent to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics, which would include compliance with relevant performance standards for examination gloves. The specific details of performance testing, sample sizes, and ground truth establishment (as relevant for non-AI diagnostic devices) are not included in this high-level regulatory clearance letter.

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