DexiPro Examination Gloves
Disposable Powder-Free Nitrile Gloves，Blue
Amazing value and one of the most cost effective brands on the market.
Classification of the product:
• 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 15D15 YN2P Ireland ; Notified Body Number: 2777
• ISO9001:2015
• ISO13485:2016
Gloves tested according to Harmonised Standards:
• EN374-1 – chemical resistance
• EN374-5 microbiological resistance
• EN455 – 1, 2, 3, 4 – medical devices
• EN21420- physical attributes
Product mentioned above complies with:
• The General Safety and Performance requirements of Annex I, Medical Device Regulation (EU)
2017/745 for Class I Medical Devices and with the Article 19 requirements.
• 2002 UK Medical Device Regulations, as amended.
