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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, JR Medic Latex Surgeon's Gloves Sterile Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile 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(2015), Standard Specification for Rubber Surgical Gloves. 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 using Gamma irradiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

The provided document describes the acceptance criteria and a study proving that JR MEDIC Latex Surgeon's Gloves Sterile Powder Free meet these criteria.

Here's the breakdown of the information requested:

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

• ISO 11137-1-2006/ (R) 2010 - validation of sterilization process.
• ISO 11137-2:2013, sterilization of health care products - radiation - part 2: establishing the sterilization dose.

8. The sample size for the training set

This is not applicable as this is a non-clinical bench test for a physical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the reasons stated above.

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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 with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound fromcontamination. The proposed device is made of' natural rubber latex, as per standard ASTM D35 77-09(2015). 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 10-6 and place in a sterility maintenance package to ensure a shelf life of 3 years.

This document is a 510(k) Premarket Notification for Latex Surgeon's Gloves Powder Free with protein content labeling claim of 50 µg/dm² or less per glove of extractable protein.

Here's a breakdown of the requested information based on the provided text:

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

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