CERTIFICATIONS NEEDED TO EXPORT MEDICAL GLOVES TO EUROPE AND US MARKET

The current situation of the Covid-19 pandemic has not shown any signs of improvement, especially in Asia, Europe, and America, the number of infections is increasing every day. Facing that situation, it seems that medical equipment products, medical materials, especially gloves, seem to be exhausted and in short supply.

In addition to medical masks and protective gear, medical gloves become important protective equipment, helping to prevent direct contact with patients to fight virus infection to protect nurses and doctors. Therefore, many companies have produced and exported medical gloves to foreign markets.

However, the European and American markets always have difficult and cumbersome regulations on export procedures or medical gloves. They need European and American certifications.

Medical gloves exported to the US must meet FDA standards

FDA, known as the US Food and Drug Administration, is an organization that stands out to protect and promote public health with extremely strict criteria. And medical gloves exported to the US meet FDA standards, which means that the product must meet the strict criteria set by the FDA. Medical gloves currently have 2 types: powder-free and powdered, but according to new FDA regulations, powdered medical gloves are not included in the list of standards for export.

Therefore, medical gloves made in Vietnam must meet FDA standards to export to Europe and America. These gloves are manufactured and monitored under strict regulations including ISO 9001:2015, ISO 22000:2005, and ISO 13485:2016.

For medical products exported to the US, Vietnamese companies need to provide a full FDA certificate for this item. Especially for powder-free Nitrile medical gloves, the import tax in the USA for this item is 0%, and US customs does not require FDA for this item.

In addition, in the European market, a CE certificate is also required. This is a product certification that complies with the legislation of the European Union. This certification entitles the product to free circulation in the market in the entire European region.

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