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Certifications & Compliance

Certified for
Global Markets.

Everything distributors and procurement teams need to specify and import our gloves with confidence, the accreditations we hold and the standards every glove is tested against.

Accreditations & Market Approvals

Recognised Where It Matters.

Independently audited and approved for the world's most demanding regulated markets.

  • SMETA 4-Pillar

    Sedex ethical audit, labour, health & safety, environment and business ethics.

  • ISO 9001

    Quality Management System governing every stage of production.

  • EN ISO 13485

    Quality Management System specific to medical devices.

  • EU MDR

    Compliance with the EU Medical Device Regulation (2017/745) for medical gloves placed on the European market.

  • CE / PPE

    European conformity under the PPE Regulation (EU) 2016/425 and EN 455.

  • US FDA

    Cleared for the US market, medical examination and food-contact use.

  • Australia TGA

    Listed with the Therapeutic Goods Administration for the Australian market.

  • Health Canada

    Medical device licensing for the Canadian market.

Tested to Standard

The Standards Behind Every Glove.

Each product page lists the exact classification for that glove. Across the range we certify to:

Quality & Medical

  • ISO 9001Quality Management System
  • EN ISO 13485Medical-device Quality Management System
  • EN 455 (Parts 1–4)Medical gloves for single use, holes, physical properties, biological evaluation & shelf life

Food Contact

  • US FDA 21 CFR 177.2600Rubber articles intended for repeated food contact
  • EU Regulation 10/2011Overall Migration, materials in contact with food

Chemical & Biological Protection

  • EN ISO 374-1:2016+A1:2018Permeation classification (Type B / Type C)
  • EN ISO 374-4:2019Degradation by chemicals
  • EN ISO 374-5:2016Protection against bacteria, fungi and viruses

Biodegradability, Bio Nitrile

  • ASTM D5511Anaerobic biodegradation in high-solids conditions
  • ISO 15985Anaerobic biodegradation and disintegration

Ethical Manufacturing

Audited on All Four Pillars.

Our facility is audited under SMETA (Sedex Members Ethical Trade Audit) across all four pillars, so partners can source from us with confidence in how our gloves are made, not just how they perform.

  • Labour standards
  • Health & safety
  • Environment
  • Business ethics

Need Documentation for a Product.

We provide Declarations of Conformity, technical data sheets and test certificates for specific products on request.

Request Documentation Browse the Range