Conformity To Standards
Quality Management System
HBM Quality Management System EN 13485 is audited and monitored by DEKRA (Notified Body identification number 0344)
Certificate validity may be verified by visiting their website.
Medical Device Directive
HBM is audited and monitored by DEKRA (Notified Body identification number 0344) for conformance to Medical Device Directive 93/42/EEC and relevant European standards for Surgical Gloves. EC Certificate and CE Mark certificate validity may be verified at their website or by emailing them: medical.nl@dekra.com
Personal Protective Equipment certification & Chemical Permeation Testing
HBM Surgical Gloves have a PPE certificate issued by SATRA Ireland (Notified Body identification number 2777) satisfying the applicable essential health and safety requirements of Annex II of the PPE Regulation EU 2016/425 as a category III product. Certificate available upon request. Please call for details.
Chemotherapy Drug permeation and other chemical permeation tests reports are available upon request. Please call for details.
Corporate Social Responsibility & Environmental Compliance
Our Mission of Honest Better Mutual encompasses our commitment to creating positive transformational changes in human rights, community, environment, and corporate governance.
We are committed to finding ways to consume less energy and resources as well as support our local community. Ethical behaviour and a safety culture are central to what we do.
4S HBM & HBM work regularly with independent audit organisations to ensure your business and ours continues to grow sustainably.
We understand that Corporate Governance is a critical component of our distribution partners requirements.