CLEARDIY testing's are mandatory sections in FDA 510k submission for examination and surgical gloves, most of the cases these tests are conducted on a third-party lab. Besides the biocompatibility testing, the below in-house tests are also required in 510k notification and test results must comply with approved standards like ASTM and ISO.
OUR GLOVE PRODUCTS FULLY COMPLY WITH THE STANDARDS OF ALL COUNTRIES IN THE WORLD
CLEARDIY testing's are mandatory sections in FDA 510k submission for examination and surgical gloves, most of the cases these tests are conducted on a third-party lab. Besides the biocompatibility testing, the below in-house tests are also required in 510k notification and test results must comply with approved standards like ASTM and ISO.
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices, which will soon change under the new Medical Devices Regulation (MDR 2017/745).
ASTM D6319 covers certain requirements for nitrile rubber gloves used in medical applications. Standard specifies various test methods including sterility testing, physical dimensions testing, physical requirements testing, powder residue, and powder limit testing. This page covers physical requirement tests to determine the tensile strength and the ultimate elongation of medical glove samples.
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
OUR GLOVE PRODUCTS FULLY COMPLY WITH THE STANDARDS OF ALL COUNTRIES IN THE WORLD
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