Disposable Powder-Free Nitrile Examination Gloves，Blue in a Case of 10 boxes (100 Gloves per Box, 1000 boxs per case)
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 – 1,3, 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.
The Workwear co. has a highly developed production and shipping system and we make every effort to ship your order in a fast and effecient manner.
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