. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/365 
23 February 2010  
 (10-0970) 
Committee on Technical Barriers to Trade Original:   English 
  
 
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Member to Agreement notifying:  BRAZIL
  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  Brazilian Sanitary Surveillance Agency – ANVISA 
Name and address (including telephone 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 :   
National Institute of Metrology, Standa rdization and Industrial Quality-INMETRO 
Tel.:  +(55) 21 2563.2821 Fax:  +(55) 21 2502.6542 Email:  barreirastecnicas@inmetro.gov.br Website:  http://www.inmetro.gov.br/barreirastecnicas
 
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):  Surgical and non-surgical 
gloves under sanitary control.  
5. Title, number of pages and language(s) of the notified document:  Draft Resolution nº 13, 
27 January 2010 – surgical and non-surgical gl oves under sanitary control (6 pages, 
Portuguese).  
6. Description of content:  This technical regulati on establishes the minimum requirements of 
identity and quality of surgical gloves and non- surgical gloves made of natural rubber, 
synthetic rubber, a mixture of natural and synthetic rubber and polyvinyl chloride, under 
sanitary control, as specified in the Annex of the Resolution.  
Surgical gloves and non-surgical gloves made of natural rubber, synthetic rubber, a mixture of 
natural and synthetic rubber and polyvinyl chlori de, under sanitary control,    must also meet 
the requirements for certification under th e Brazilian Conformity Assessment System 
(SBAC). 
According to the paragraph of Art. 2,  dome stic manufacturers and importers may choose the 
type of certification under the SBAC.  
The companies have a period of 180 days to adequate to the Resolution, after its entry into 
force.  G/TBT/N/BRA/365 
Page 2  
 
  The Resolution is based on the following In ternational Standards: ISO 11193-2:2006 Single-
use medical examination gloves: part2: spec ification for gloves made form poly(vinyl 
chloride); ISO 10282:2005(E) Si ngle sterile rubber surgical gloves; ISO 37:2008 Rubber, 
vulcanize or thermoplastic – determination of tensile st ress-strain properties.  
The Resolution is also based on the following Standards: European Commission, Health & 
Consumer Protection Directorat e-General, Scientific Commi ttee on Medical Products and 
Medical Devices, Opinion on Natural r ubber latex; June 27th 2000;  ABNT, NBR 
Nº 5426:1985;  ABNT, NB R ISO Nº 11193-1:2009. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of Human Health and Prevention of Deceptive Practices  
8. Relevant documents:   Brazilian Official J ournal (Diário Oficial da União), 1 February 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 13, 27 January 2010, issued by 
Brazilian Sanitary Surveillance Agency – A nvisa; When adopted, it will be published at 
Brazilian Official Journal. Available in Portuguese.   
9. Proposed date of adoption:   
 
Proposed date of entry into force:    To be determined after the end of the 
consultation period.  
On the date of adoption. 
10. Final date for comments:  1 April 2010 
11. Text available from: National enquiry point [X], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
Agency responsible 
Brazilian Sanitary Surveillance Agency – ANVISA SIA, Trecho 5, Área Especial 57 Brasília – DF / Brazil 
CEP:  71.205-050 
Phone:  55 61 3462-5402 E-mail:  rel@anvisa.gov.br  Website:  http://www.anvisa.gov.br
 
http://portal.anvisa.gov.br /wps/wcm/connect/13f60 a804138952ebcb1bdc5ae04202e/CP+N%
C2%BA+13+GGTPS.pdf?MOD=AJPERES