. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/BRA/367 
11 March 2010  
 (10-1321) 
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 
Telephone: +(55) 21 2563.2821 Fax: +(55) 21 2502.6542 
Email: barreirastecnicas@inmetro.gov.br
 
Website: www.inmetro.gov.br/barreirastecnicas  
 
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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 14, 
27 January 2009 – surgical and non-surgical glov es under sanitary control (15 pages, in 
Portuguese). 
6. Description of content:  This regulation and conformity as sessment procedure establish the 
conditions for verification of   the minimum re quirements 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 this Regulation.  
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,   must be sampled 
and inspected according to Standard ABNT NBR 5426. The levels of inspection and 
acceptable quality level (AQL) must be in accord ance with those specified in Table 1 of this 
regulation.  
The labelling of packages 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, must attend the provi sions of Annex E of this regulation.  
The companies have a period of 180 days to adequate to the Resolution, after its entry into 
force.  G/TBT/N/BRA/367 
Page 2  
 
  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 Journal (Diári o Oficial da União) , 1 February 2010; 
Section 1. Draft Resolution (Consulta Públic a) number 14, 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:  www.anvisa.gov.br  
 http://portal.anvisa.gov.br /wps/wcm/connect/041f278 0413896e2bcc2bdc5ae 04202e/CP+N%
C2%BA+14+GGTPS.pdf?MOD=AJPERES