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The X-Ray protection gloves PROGUARD are sterile examination gloves, radio-opaque, to be worn by hospital personnel, specifically surgeons, to protect their hands from radiation during operation of x-ray equipment. These gloves are destined to specific examination purposes. They are not intended to be used instead of a Radiographic Protective Gloves, normally used in radiography for those studies which need the physician's hands or forearms to be inserted intop the primary x-ray beam, but not the sterility or the degree of manual dexterity allowed by the PROGUARD.

Moreover these gloves are not to be used in or next to the primary x-ray beam or conducted primary x-ray beam. The main purpose of these gloves is to reduce the amount of dispersed radiation exposure to the hands from the primary x-ray beam during examinations or procedures under fluoroscopy performance.

This product contains natural rubber latex. The gloves are a product of Malaysia. The manufacturer of these latex-lead gloves complies with all the current specifications listed under The American ociety for testing and Materials (ASTM) Specification D 3578 -91 and FDA Water Leak Test.

The quality assurance testing for the finished product includes testing for physical properties such as tensile strength and elongation: dimensions such as length, width and thickness; visual tests such as colour and material uniformity. In addition, sampling and testing for leaks conforms to the FDA Water Leak Test for patient examination gloves.

The provided text describes safety and effectiveness information for X-Ray protection gloves, but it does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The document is a 510(k) summary for a physical medical device (X-Ray protection gloves) from 1998. It details the physical properties of the gloves, their intended use, and a caution statement. It also includes an FDA clearance letter for the device, confirming its substantial equivalence to previously marketed devices.

Therefore, I cannot extract the requested information using the provided input. The questions you've asked are specific to the evaluation of AI/SaMD performance, which is not covered in this document.

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