Quality & Compliance
Quality Certified to
Global Standards
Lalan Rubbers has its compliance with international quality, safety, social responsibility and environmental standards regularly audited by independent bodies.
Quality & Medical
ISO 9001
Quality Management SystemThe international quality management system standard that ensures Lalan's products and services consistently meet customer and regulatory requirements.
ISO 13485
Medical Device Quality ManagementA certificate documenting that Lalan's quality management system for the laboratory and medical device sector complies with international standards. Mandatory for medical-grade gloves.
Market Access
FDA
US Food-Contact ApprovalLalan's food-safe gloves are certified under FDA Title 21 CFR, documenting that the glove components comply with food safety regulations and contain "substances generally recognized as safe for use in food or food packaging."
FDA 510(k)
Medical Device Premarket NotificationDemonstrates that Lalan gloves marketed as medical devices in the US have successfully completed the FDA premarket notification process (510k) and meet safety and efficacy requirements.
Health Canada
Canadian Market ComplianceApproval from Canada's federal health authority documenting that Lalan gloves meet the requirements under the Canadian Food and Drugs Act (FDA) and its Regulations (FDR).
Chemical & Environment
REACH
Chemical Substance SafetyDocuments that Lalan adopts the EU chemicals regulation and manages the risks to human health and the environment of the chemicals used in production in line with EU regulations.
GOTS
Organic Textile StandardGOTS is an organic textile production certification that restricts the use of toxic bleaches, dyes and other chemicals in Lalan's production process. It covers the entire chain from raw material to labelling.
ASTM International
Material & Testing StandardsLalan applies ASTM standards to improve product quality, strengthen health and safety, facilitate market access and demonstrate to customers that they can rely on the products.
Social & Ethical
BSCI
Social Compliance AuditUsing the BSCI social audit methodology, Lalan continuously improves and maintains working conditions across all its facilities at the highest level. Covers human rights, ethical business practices and supply chain transparency.
Sedex
Responsible Supply ChainSedex (Supplier Ethical Data Exchange) allows Lalan to catalogue and share information on its ethical and social compliance performance with its partners, ensuring a sustainable and transparent supply chain.
BRC Global Standards
Food Safety & QualityA global standard for food-sector suppliers. Under BRC Consumer Products Certification, Lalan documents the safety, legality and quality of product design as well as the food-safety suitability of the production environment.
Sanitized®
Antimicrobial ProtectionThe SANITIZED® antimicrobial treatment is applied to selected Lalan products to protect gloves against the colonisation and proliferation of bacteria, mould, mildew, algae or dust mites.
Policy Documents
34 DocumentsNeed Certification Documents?
Official certificate copies and compliance documents are provided on request.