Personal Protective Equipment (PPE) Testing

About HTW Laboratory:

HTW Lab can guide you through the testing process step by step for your medical device products, and help you meet regulatory standards for global market access. For technical regulation support, technicians at HTW are able to help you understand technical regulations and product design specifications. 

We are experienced in supplying one stop service for globe market access (such as NMPA, FDA, CE-MDR, CE-IVDR, CMDCAS, ANVISA). Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation.

Testing Scope

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. 

Why Choose Us?

HTW Lab, accredited by CNAS, CMA, CNCA & A2LA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of Good Laboratory Practice (GLP) and provides product testing service in accordance with national and global standards for both active and non-active medical devices. We are also IECEE CB Scheme Test Laboratory (CBTL). Thus, testing reports from HTW Lab can be accepted between countries.

Your Benefits at a Glance:

1.20 Years of experience

HTW has extensive experience in all types of devices and regulatory requirements across markets. 

2.Provide free modification service

Together with our wealth of knowledge in complex regulations globally, HTW provides a complete suite of testing solutions according to your needs including free modification service.

3.Save time to global markets

With over 7,000 square meters of labs, HTW offers the best testing cycles and you don't have to wait in line, HTW offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, HTW can optimize your costs and minimize your time to market.

4.Complete qualifications

ISO/IEC 17025 lab, accreditated by CNAS, CMA,A2LA,GLP.

5.Competitve price

Testing costs are lower than other labs.

Email:

sales@htwlab.com

You can also contact us directly by email.