Surgical glove in pure natural rubber latex.
The micro-rough surface ensures optimal grip, the anatomical shape guarantees maximum sensitivity.
Totally free of talc.
Suitable for hospital, outpatient and dressing use.
GENERAL DESCRIPTION OF THE MEDICAL DEVICE
The product is certified as a class IIa medical device. In compliance with the provisions of the GUIDELINES FOR THE DEFINITION OF THE SAFETY AND ENVIRONMENTAL HYGIENE STANDARDS OF THE OPERATING DEPARTMENTS drawn up by ISPESL, the gloves have been tested to define the ability to be a barrier and offer valid protection against viral agents and pathogenic microorganisms, ensuring
the impermeability of the gloves to body and blood fluids that may contain such infesting agents.
GENERAL DESCRIPTION OF THE INDIVIDUAL PROTECTION DEVICE
The product is certified by the Notified Body CE 0465 as PPE CLASS III for protection from MECHANICAL, CHEMICAL AND BIOLOGICAL RISKS, in accordance with the provisions of LEGISLATIVE DECREE No. 475 - implementation of Directive 89/686 / EEC Directive.
The product complies with the obligations established by the EC 1907 / 2006_REACH Regulation, the registration, evaluation, authorization and restriction of chemical substances and preparations within the European Union, to safeguard human health and the environment.
REFERENCE REGULATION Legislative Decree no. 37/2010, EEC Directive 93/42, Directive 47/2007 Pharmacopoeia Italian Republic Current edition, European Pharmacopoeia Current edition UNI EN ISO 11137 EN 455 I - II - III - IV, EN 374 I - II - III, EN 420 , EN 388, ASTM F1671 ISO 2859 EC Regulation 1907/2006 REACH.
COMPOSITION: Natural rubber latex
STERILIZATION:
Through ETO. Sterility analysis according to USP ed.corr.
LUBRICANT TREATMENT:
Lubricating treatment by coating with inert and biocompatible polymeric film.
Amount of residual lubricating powder (ASTM D6124) <2.0 mg / glove
Complies with European standards EN 455 - EN 374
AQL <1.5
CE Class II A Medical Device
PACKAGING:
Pair packed individually
