Personal Protective Equipment (PPE) Testing
Protective gloves are used in many situations to protect human skin during wet work or against mechanical or thermal injury, infections, or chemicals and drugs, thus reducing the risk to human health significantly. However, it is essential to find the appropriate gloves for each specific purpose.
Disposable gloves can be Medical Devices, Personal Protective Equipment (PPE) or both, as per the European Directive of medical devices and PPEs Regulation. When forming part of PPE, gloves fall under Category III PPE and, in addition to undergoing a certification process by an EU Notified Body, they need to meet one of the following requirements: conformity to type based on internal production control (Module C2), or conformity to type based on quality assurance (Module D).
MD gloves: If the gloves are a nonsterile Medical Device, they fall under Class I. Disposable medical gloves which are used to prevent the spread of infection or illness must observe the following standards, according to Medical Devices Directive 93/42/EEC: EN 455-1,2,3,4.
HTW Testing and Certification Solutions.
Domestic Registration/Global Market Access
China NMPA (CFDA)
US FDA (Listing, 510k)
Brazil ANVISA (INMETRO, ANATEL )
EMC single test site rental service;
EMI, EMS, RF testing, report issuance;
Product certification services, obtained certificates issued by certification agencies in various countries;
EMC countermeasure rectification service;
EMC consulting, coaching and training for product design;