About this document
CE Declaration for Nitrile Gloves by IAS India is a document available to read on EtoBox.
Dexasia Technologies Sdn. Bhd declares that their nitrile gloves comply with EU safety and performance requirements for medical devices. The gloves meet standards for material properties, biocompatibility, and cleanliness according to EN 455-2:2015, EN 455-3:2015, and EN 455-1:2000. The nitrile gloves are classified as a Class I non-sterile medical device under the EU Medical Device Regulation 2017/745. Dexasia is authorized to affix the CE marking to indicate conformity for their nitrile gloves.
- Author
- IAS India
- Language
- EN