G-VIR® glove is a IIa class medical device compliant with the European Directive 93/42/EEC and with various national implementations of this text.

To obtain the CE Mark, Hutchinson Santé followed the CE declaration procedure in compliance with Annexe II of the Europen Directive (excluded point n°4).The entire Quality Assurance System had been audited and certified by the Natified Body called SGS (0120).

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