PRESS RELEASE ARCHIVES
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
February 12, 2020
Sempermed USA, one of the world's leading manufacturers and suppliers of hand protection, is pleased to announce the rebranding of the SemperGuard® Vinyl Powder-Free glove product line. The inner box and outer case artwork have been updated to reflect a refreshed, modern industrial design that continues to follow Sempermed’s color-coding system by size. As for the physical gloves and the dimensions of the box/case, we increased the weight of the glove from a 4.0 gram to a 5.5 gram in order to meet the demands of the industrial glove market. The box/case dimensions had to be updated slightly to properly fit and package the new weight glove.
February 19, 2020
Sempermed USA, one of the world's leading manufacturers and suppliers of hand protection, is pleased to announce the rebranding of the SemperGuard® Latex Powder-Free glove product line. The inner box and outer case artwork have been updated to reflect a refreshed, modern industrial design that continues to follow Sempermed’s color-coding system by size. Please note, neither the physical gloves or the dimensions of the box/case have changed. This is the same great glove, just in a new updated package. The box/case will display a “Same Great Glove - New Package” logo.
February 21, 2020
Just a friendly reminder, FDA enforcement of Unique Device Identification (UDI) labeling and data submission for Class 1 medical devices, including disposable surgical and examination gloves, will begin on September 24, 2020.
February 21, 2020
The newly-named Covid-19, also known as novel-Coronavirus, is creating increasingly stringent containment measures throughout China. Quarantine and travel restrictions accompanied by worker shortages, transportation limitations, and significant increases in domestic personal protection equipment demand has resulted in increased delivery times for vinyl, nitrile, and latex gloves. Lead times have been extended from 8 weeks to 16 weeks or more based on product demand. This global issue is affecting all glove suppliers worldwide.
March 27, 2020
Covid-19 is having a significant impact, not only on our day-to-day lives, but also on the global supply chain and factory capacity relating to disposable hand protection. The demand for disposable hand protection and other PPE has increased to never-before-seen levels. These demands have stressed factories and the supply chain to the point that shortages are being seen in the marketplace. Production lead times on many products have increased from a few months or less to several quarters or more in just the last 45 days.