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Italy-Roma: Disposable gloves
Section I: Contracting authority
Main address: http://www.carabinieri.it/Internet/
Address of the buyer profile: http://www.carabinieri.it/Internet/
Section II: Object
Accelerated Open Procedure for the Conclusion of a ‘Framework agreEment’ lasting 12 Months, with a Single Economic Operator, for the Supply of No 10 000 000 Nitrile Gloves
Supply of non-sterile, powder-free disposable nitrile gloves at the unit price of EUR 0.14 plus VAT if due, falling within the scope of: Class I medical devices (Directive 93/42/EEC implemented with Legislative Decree No 46/97 as amended by Directive 2007/47/EC and implemented with Legislative Decree No 37/2010); III cat. personal protective equipment pursuant to UNI EN ISO 374-1: 2018 and UNI EN ISO 374-5: 2017 (Reg. 2016/425/EU).
At the clothing warehouse of the Carabinieri which will be indicated in the implementation contract/executive order.
Supply of non-sterile, powder-free disposable nitrile gloves at the unit price of EUR 0.14 plus VAT if due, falling within the scope of: class I medical devices (directive 93/42/EEC implemented with Legislative Decree No 46/97 as amended by Directive 2007/47/EC and implemented with Legislative Decree No 37/2010); III cat. personal protective equipment pursuant to UNI EN ISO 374-1: 2018 and UNI EN ISO 374-5: 2017 (Reg. 2016/425/EU).
Section III: Legal, economic, financial and technical information
All economic operators provided for by art. 45 of Legislative Decree No 50/2016, including the competitors specifically and temporarily grouped pursuant to art. 45, paragraph 2, lett. (d) of Legislative Decree No 50/2016 and aggregations between companies adhering to the network contract pursuant to art. 45, paragraph 2, lett. (f) of Legislative Decree No 50/2016, according to the procedures indicated in the tender regulations.
All economic operators wishing to compete in this tender must produce, together with the remaining documentation provided for in this announcement and in the tender regulations, under penalty of exclusion from this procedure, the quality certification inherent to the ISO 9001 quality management system, in course of validity, issued by an accredited ACCREDIA body or another body in mutual recognition. In the case of R.T.I. (constituting or constituting) said certification must be in possession of all the economic operators gathered.
In addition, with reference to the manufacturer of the nitrile gloves that the competitor intends to offer, the following documentation must be produced — under penalty of exclusion from the tender
(a) certification relating to the quality management system UNI CEI EN ISO 13485: 2016/AC: 2018 regarding the requirements that allow an organisation to demonstrate its ability to provide medical devices and related services that comply with the regulatory requirements applicable to such devices doctors.
(b) CE certification pursuant to UNI EN 374: 2016, currently valid, relating to the product to be offered, issued by a notified body, verifiable by accessing the ‘NANDO’ system of the European Commission, which registers all the notified bodies for the EU Regulation 425/2016 at the link: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=380 or through the website of the Italian Accredia Accreditation Body (www.accredia.it), pursuant to Regulation (EU) 2016/425 on personal protective equipment (PPE).
In particular, the aforementioned certification must be issued in compliance with:
— UNI EN 374-1 (resistance to chemical products and dangerous microorganisms), Type B — the permeation characteristics must be at least level 2 with respect to a minimum of three test chemicals among those listed below:
Code Letter Chemical Cas Number Class
J n-Heptane 142-82-5 Saturated hydrocarbon
K Sodium hydroxide 40 % 1310-73-2 Inorganic base
P Hydrogen peroxide 30 % 7722-84-1 Peroxide
T Formaldehyde 37 % 50-00-0 Aldehyde.
— UNI EN 374-5 (resistance to the passage of viruses).
(c) EN 455 certification, in particular:
— EN 455-1 (LQA of 1.5) — absence of holes;
— EN 455-2 with reference to surgical gloves, both for the parameters of dimensions and breaking load before aging — physical properties requirements and tests;
— EN 455-3 - biological evaluation;
— EN 455-4 - determination of shelf life.
(d) declaration of conformity according to Annex IX of Reg. (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.
All the aforementioned certifications required and the related test reports must be:
— in the name of the manufacturer;
— referring to the model of gloves supplied.
In particular, the certification certificates must also bear the number of the corresponding test report.
Section IV: Procedure
Urgent need to provide logistical support that is adherent and functional to the operations of the departments.
Electronic trading platform made available by Consip S.p.A. (as system manager), on the website www.acquistinretepa.it
Section VI: Complementary information
(a) The procurement procedures referred to in this announcement have been authorised — pursuant to art. 32, co. 2, of Legislative Decree No 50/2016 — with determines to contract No 885 R.U.A. on 24 August 2020.
(b) The tender will be carried out according to the procedures established by Legislative Decree No 50/2016 and will be awarded even in the presence of only one valid offer, in consideration of the urgency of having the materials in question, which would be prejudiced in the event of a repeat of the tender.
(c) The tender regulations, which contain all the conditions of participation, together with the relative annexes, the technical specifications and the draft of the framework agreement are available, together with this announcement, on the website www.carabinieri.it in the ‘administration transparent,’ subsection ‘calls for tenders and contracts,’ at the following URL: http://www.carabinieri.it/cittadino/informazioni/gare-appalto/gare-appalto/fornitura-nr.-10.000.000-guanti-in-nitrile-per-esigenze-covid-19 and on the website www.acquistinretepa.it (initiative name: open procedure for the supply of nitrile gloves in the context of the Covid-19 health emergency — initiative number/code: 2638426 accessible from the ‘other tenders’ subfolder).
(d) Subcontracting is prohibited due to the certification required by the competing economic operator and by the manufacturer of the nitrile gloves offered for participation in this contract.
(e) The D.U.V.R.I. has not been drawn up due to the absence of interference.
(f) The tender identification code (C.I.G.) attributed to this proceeding by the A.N.AC is: 84136771E8.
(g) This call for tenders has been sent for publication in the Official Gazette to the Publications Office of the European Union on 9 September 2020.
(h) Pursuant to EC Regulation No 593 of 17 June 2008 of the European Parliament and of the Council, Italian law will be applied to the contractual obligations deriving from this tender.
(i) The person in charge of the procedure is the pro-tempore Head of the Single Contractual Center of the General Command of the Carabinieri.
(j) Director of the execution of the contract will be appointed at the time of completion of each descendant implementation contract/supply order.
Internet address: http://www.carabinieri.it/Internet/
30 days from notification or from actual knowledge of the award, to appeal to the competent Regional Administrative Court of Lazio, Rome office.