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A latex surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterilized and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09. The classification is: Type I - gloves compounded primarily from natural rubber latex". The proposed device is Powder Free Latex Surgeon's Gloves, and variants of different sizes. All variants share the same color, creamy, white. The proposed device is sterilized either using Ethylene Oxide Sterilization or Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 +and place in a sterility maintenance package to ensure a shelf life of 3 years.

This document is a 510(k) premarket notification for a medical device: "Pristeen (Latex Surgeon's Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein)".

The acceptance criteria and study proving the device meets those criteria are detailed through non-clinical testing against established ASTM and ISO standards for surgical gloves.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

2. Sample sizes used for the test set and the data provenance:

The document describes non-clinical bench testing according to specific ASTM and ISO standards. While the results (average values) are presented, the exact sample sizes used for each physical and chemical test are not explicitly detailed in this document. The provenance of the data is from the manufacturer's internal testing as part of their 510(k) submission, implied to be prospective testing for regulatory compliance. The manufacturer is Beta Healthcare Products Pvt. Ltd. from Kerala, India.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a non-clinical bench testing. Therefore, no human experts were involved in establishing "ground truth" in the way one would for diagnostic imaging studies. The "ground truth" or acceptance criteria are defined by established international standards (ASTM D3577-09, ASTM D5151-2011, ASTM D6124-2011, ASTM D5712-10, ASTM D6499-12, ASTM F1929-2004, ISO 10993-10:2010, ISO 11137-2:2013, ISO 10993-7:2008, ISO 11135-1:2007). Performance is measured against these universally accepted benchmarks.

4. Adjudication method for the test set:

Not applicable. This is not a human interpretation study. The compliance is determined by objective physical and chemical measurements against pre-defined standard specifications.

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 document pertains to the regulatory clearance of surgical gloves, which are physical medical devices, not AI/software as a medical device (SaMD). Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software.

7. The type of ground truth used:

The "ground truth" for the performance evaluation are established international standards and specifications (e.g., ASTM D3577-09 for physical properties, ASTM D5151-2011 for pinholes, ISO 10993-10 for biocompatibility). The device performance is measured against these objective, scientifically validated standards.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/machine learning model. There is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As there's no training set, there's no ground truth for it. The ground truth for the device's performance, as stated in point 7, is based on adherence to recognized industry standards.

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