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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:

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