January 17, 2020
On September 24, 2013, the Food and Drug Administration (FDA) established a unique identification system to adequately identify medical devices. The label of most devices must include a Unique Device Identifier (UDI) in human-and-machine readable format.
January 31, 2020
In December 2019, an outbreak of a novel type of coronavirus was identified in Wuhan, the capital city of the Hubei Province in Central China. The virus has resulted in an increasing number of fatalities in China and it has been confirmed in many additional countries. This Novel Coronavirus (2019-nCoV) belongs to the Coronaviridae family. Other viruses in this family are the Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Because there is evidence of human-to-human transmission, and a continued risk of infection, we would like to assure you that all medical gloves offered by Sempermed® are Class I medical devices and are tested according to the following standard:  ASTM F1671: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System