G/TBT/N/ECU/317  
7 May 2015  
(15-2429)  Page: 1/2  
Committee on Technical Barriers to Trade  Original: Spanish  
 
  NOTIFICATION 
The following notification is being circulated in accordance with Article 10.6. 
 
1. Notifying Member: ECUADOR 
If applicable, name of local governme nt involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Servicio Ecuatoriano de Normalización , SEN (Ecuadorian Standardization Service) 
Calle Baquerizo Moreno E8-29 y Diego de Almagro Tel.: (+593-2) 2501885 Fax: (+593-2) 2567815 
Email: PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.normalizacion.gob.ec/  
Name and address (including telephon e and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:  
Subsecretaría de la Calidad (Under-Secretariat for Quality) 
Ministerio de Industrias y Productividad , MIPRO (Ministry of Industry and Productivity) 
Address: Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2358 or 2253 
Email: mmartinez@mipro.gob.ec ; PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.industrias.gob.ec/  
3. Notified under Article 2.9.2 [X], 2. 10.1 [ ], 5.6.2 [ ],  5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided  in addition, where applicable): 39262000, 
39269090, 40151100, 40151990 and 40159090. 
5. Title, number of pages and lang uage(s) of the notified document: Proyecto de 
Reglamento Técnico Ecuatoriano PRTE INEN 271, "Guantes quirúrgicos y de 
exploración/procedimiento para uso médico"  (Draft Technical Regulation of the Ecuadorian 
Standardization Institute (PRTE INEN) No. 271, "Surgical gloves and examination/procedure gloves for medical use") (8 pages, in Spanish)  
6. Description of content: The notified draft Technical Regulation covers the following: 
Purpose; Scope; Definitions; Product requirements; Labelling requirements; Sampling; 
Conformity assessment tests; Reference documents; Conformity assessment procedure; 
Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. G/TBT/N/ECU/317 
- 2 - 
  7. Objective and rationale, including the nature of urgent problems where 
applicable: The notified Technical Regulation establishes the performance and safety 
requirements to be met by medical gloves for single use, with a view to protecting human 
life and safety and preventing practices th at may lead to misuse of the product. 
It applies to the following domestically manufactured or imported gloves intended for 
medical use to protect the patient and user from cross-contamination, which are marketed 
in Ecuador: 
 Surgical gloves. Sterile, medical and an atomically-shaped gloves with the thumb 
positioned towards the palmar surface of the index finger, rather than lying flat, 
which are intended for use in invasive surgery, aseptic techniques in medical 
procedures and laboratory procedures requiring sterile conditions. 
 Examination/procedure gloves. Sterile or  non-sterile gloves, whether or not 
anatomically shaped, intended for the performance of medical tests or examinations, 
diagnostic or therapeutic procedures, and laboratory procedures, and also for the 
handling of contaminated and non-contaminated medical material, which do not require sterile conditions. 
8. Relevant documents:  
 Publication where notice appears: http://www.industrias.gob.ec/ ; 
http://www.normalizacion.gob.ec/  
 Proposal and basic document: Proyecto de Reglamento Técnico Ecuatoriano PRTE 
INEN 271, "Guantes quirúrgicos y de ex ploración/procedimiento para uso médico"  
(Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) 
No. 271, "Surgical gloves and examinatio n/procedure gloves for medical use") 
 Publication in which Technical Regulation will be published when adopted: Registro 
Oficial  (Official Journal). 
9. Proposed date of adoption: 90 days from 4 May 2015 
Proposed date of entry into force: 180 days from date of adoption  
10. Final date for comments: 2 August 2015 
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresse s, if available, of other body:  
Contact and/or National Enquiry Point: 
Marlon Martínez 
Subsecretaría de la Calidad 
Ministerio de Industrias y Productividad, MIPRO Address: Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador 
Tel.: (+593-2) 3948760, Ext. 2358 or 2253 
Email: mmartinez@mipro.gob.ec ; PuntocontactoOTCECU@mipro.gob.ec  
Website: http://www.industrias.gob.ec/