Description

DexiPro Examination Gloves
Product Codes: 95896 (S/7) – 95899 (XL/10)

Description:
DexiPro Disposable Powder-Free Nitrile Medical Gloves offer reliable protection and comfort. They feature a vibrant blue color and are designed for single-use applications in medical, laboratory, and food-related environments.

Classification:

• CAT III PPE (EU) 2016/425
• Class I Medical Device (EU 2017/745)
• Class I Medical Device (2002 UK Medical Device Regulations, as amended)
• Basic UDI: DI 697521920EM0102156286CH-Powder Free Gloves

Certification:

• Module B, EU Type Examination (Satra 2777) – Certificate No. 2777/21028-03/E61-01
• Module D, Satra Certificate: STE2011843
• SATRA Technology Europe Ltd, Bracetown Business Park, Clonee, Dublin 15, D15 YN2P, Ireland (Notified Body Number: 2777)
• ISO9001:2015
• ISO13485:2016

Tested According to Harmonised Standards:

• EN374-1: Chemical resistance
• EN374-5: Microbiological resistance
• EN455 (Parts 1, 2, 3, 4): Medical device standards
• EN21420: Physical attributes

Compliance:

• Meets General Safety and Performance Requirements of Annex I, Medical Device Regulation (EU) 2017/745 for Class I Medical Devices and Article 19 requirements
• Complies with 2002 UK Medical Device Regulations, as amended
• Conforms to Personal Protective Equipment (PPE) Regulation (EU) 2016/425, including Annex II General Safety Requirements, Module B EU-Type Examination Certification, and Module D Quality Assurance
• EEC regulations for materials and products in contact with food (Regulation EEC 1935/2004, EC 10/2011, EC 2023/2006)

User Information:

• Suitable for contact with dry, fatty, alcoholic, and aqueous foods for short-term use
• Latex-free; contains accelerators which may cause allergic reactions
• Please retain packaging for future reference
• Store in a cool, dry place, away from excess heat (40°C/104°F) and direct sunlight

Sizing of the Medical Grade Nitrile Gloves

Please use the diagram below as a guide to measuring your hand and selecting the right size glove:

All B2B orders are handled on a quotation basis—please email or call us today for more information, you can also us our quote form see link: Click Here