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A powder-free patient examination glove is a disposable device made of natural rubber latex or synthetic material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infections materials and other contaminants.

POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTENCED OD IMER CORTED LATEX EXAMINA HON GLOVES

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

The provided text is a 510(k) premarket notification letter from the FDA to KL Kepong Rubber Products Sdn Bhd, concerning "Powder Free Polymer Coated (Acrylic Based) Latex Patient Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less)."

This document does not contain the specific information required to complete your request. It is an FDA clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, meaning it doesn't need a Premarket Approval (PMA) application. This letter does not include details about device performance, acceptance criteria, or specific studies conducted to prove the device meets performance criteria.

Therefore, I cannot provide the requested information from the given text.

To elaborate on why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This letter only states the device is "substantially equivalent" to predicate devices. It doesn't list specific performance metrics or their acceptance thresholds.
2. Sample sized used for the test set and the data provenance: There is no mention of any test set size or where the data came from.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment and expert details are not part of this type of regulatory clearance letter.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: MRMC studies are typically for diagnostic devices or AI algorithms where reader performance is a key metric. This is a physical glove, so an MRMC study would not be applicable in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This pertains to AI algorithms, which is not what this device is.
7. The type of ground truth used: Not mentioned, and generally not applicable for a physical barrier device like a glove in this context.
8. The sample size for the training set: This refers to AI algorithms; not applicable here.
9. How the ground truth for the training set was established: This refers to AI algorithms; not applicable here.

In summary, the provided document is a regulatory approval letter and does not contain the detailed study results or acceptance criteria you're looking for. Such information would typically be found in the 510(k) submission itself (the "premarket notification") rather than the FDA's response letter.

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