Brazilian Health Surveillance Agency  
www.anvisa.gov.br  
  
Draft Resolution No  13 of 27  January 2010.  
Brazilian Official Gazette ( Diário Oficial da União  – DOU) of 1  February 2010  
The Collegiate Directorate of the Agência Nacional de Vigilância Sanitária  – ANVISA 
(Brazilian Health Surveillance Agency), pursuant to the powers conferred on it by Article 
11(IV) and Article 35 of the ANVISA Regulation approved by Decree No  3029 of 16 
April 1999, and having regard to the provisions of Item V and points 1 and 3 of Article 
54 of the Internal Regulations approved in accordance with Annex I of ANVISA 
Administrative Ruling No  354 of 11 August 2006, republished in the DOU of 21 August 
2006, at a meeting held on 18 January 2010,  
hereby adopts the following Draft Resolu tion, and I, the Director -President, order its 
publication:  
Article 1 – A period of sixty days from the date of publication of this Draft Resolution is 
hereby declared open for submitting criticisms and suggestions on the proposed 
Technical Regulation layi ng down minimum identity and quality requirements for 
surgical and non -surgical gloves made of natural rubber, synthetic rubber, a mixture of 
natural rubber and synthetic rubber, or PVC, subject to health surveillance arrangements, 
attached herewith.  
Artic le 2. This full proposal will be available during the consultation period at 
www.anvisa.gov.br  and any suggestions should be sent in writing to: Agência Nacional 
de Vigilância Sanitária, Gerência Geral de Tecnologi a de Produtos para Saúde, S.I.A., 
Trecho 5, Lote Especial 57, Brasília – DF – 71.205 -050, Brazil, by fax (061) 3462 -6644 
or by email to tecnologia.produtos@anvisa.gov.br.  
Article 3 – At the end of the period stipulated in Article 1, the ANVISA will make 
contact with the interested parties and others who have expressed interest in order that 
they may appoint representatives for subsequent discussions with a view to consolidating 
the final text.  
DIRCEU RAPOSO DE MELLO  
ANNEX  
COLLEGIATE DIRECTORATE RESOLUTION ( RDC) No … of … 2010  
Laying down minimum identity and quality requirements for surgical and non -surgical 
gloves made of natural rubber, synthetic rubber, a mixture of natural rubber and synthetic 
rubber, or PVC, subject to health surveillance arrangements.  
The Collegiate Directorate of the Brazilian Health Surveillance Agency, pursuant to the 
powers conferred on it by Article 11(IV) and Article 35 of the ANVISA Regulation 
approved by Decree No  3029 of 16 April 1999, and having regard to the provisions of 
Item V and points 1 and 3 of Article 54 of the Internal Regulations approved in 
accordance with Annex I of ANVISA Administrative Ruling No  354 of 11 August 2006, 
republished in the DOU of 21 August 2006, at a meeting held on [date], and  Whereas the Ministry f or Health established a quality assurance system for related 
products by adopting the Brazilian Conformity Assessment System with a view to 
assuring the safety and quality of such materials;  
Having regard to the notifications received in relation to proble ms with the quality of 
surgical and non -surgical gloves  
Whereas surgical gloves are also used in situations that may pose a risk to patients, users 
or both  
  
Whereas there is scientific evidence that the raw material latex, as used in the 
manufacture of su rgical and non -surgical gloves, may cause allergic reactions in patients, 
users or both  
Whereas ANVISA RDC No  5 of February 2008 must be updated, the current Brazilian 
and international normative references must be brought into line, and gloves for 
protect ion against biological risks are subject to mandatory certification by the Ministry 
for Labour and Employment; and  
having regard to the need to lay down minimum requirements for surgical and non -
surgical gloves made of natural rubber, synthetic rubber, a m ixture of natural rubber and 
synthetic rubber, or PVC, subject to health surveillance arrangements, in order to 
guarantee their quality, safety and effectiveness, and to protect the health of consumers; 
hereby decides:  
Article 1 – To lay down minimum ident ity and quality requirements for surgical and non -
surgical gloves made of natural rubber, synthetic rubber. a mixture of natural and 
synthetic rubber, or PVC, subject to health surveillance arrangements, with a view to 
ensuring that the product is safe and  effective in terms of its proposed objective.  
Article 2 – Surgical and non -surgical gloves made of natural rubber, synthetic rubber, a 
mixture of natural and synthetic rubber, or PVC, subject to health surveillance 
arrangements must also meet the conformi ty certification requirements laid down by the 
Brazilian Conformity Assessment System.  
Sole paragraph: - Brazilian manufacturers and importers may choose certification by 
system assessment and product testing or by assessment on a batch -by-batch basis.  
Article 3 – The documents and provisions set out in ANNEX I – REFERENCES were 
taken into account in the drafting of this Regulation.  
Article 4 – The following definitions shall apply for the purposes of this Regulation:  
II. NATURAL RUBBER OR NATURAL LATEX RU BBER:  
Product resulting from the processing of latex by means of coagulation, drying and other 
processes, along with the addition of other ingredients.  
II. SYNTHETIC RUBBER:  
Synthetic product made of chemicals and ingredients with characteristics similar t o those 
of natural latex rubber.  III. STERILISATION:  
Physical or chemical process that eliminates all microbial life -forms, including bacterial 
spores.  
IV. SURGICAL GLOVE:  
Single -use product made of natural rubber, synthetic rubber, a mixture of natural an d 
synthetic rubber or PVC, anatomical shape, with a cuff or other closure permitting 
adjustment to the user's wrist, for use in surgery.  
V. NON -SURGICAL GLOVE:  
Single -use product made of natural rubber, synthetic rubber, a mixture of natural and 
synthetic rubber, or PVC, for non -surgical use in health care.  
VI. NATURAL RUBBER LATEX:  
Milky -white product of known composition extracted from the bark of the Pará rubber 
tree, or Hevea Brasiliensis . 
  
Article 5 – Surgical and non -surgical gloves made of natural r ubber, synthetic rubber, a 
mixture of natural and synthetic rubber, or PVC can be classified by:  
I. raw material : gloves may be:  
a) Type 1  - natural rubber;  
b) Type 2  - synthetic rubber(s) or a mixture of natural and synthetic rubber(s);  
c) Type 3  - PVC. G loves made of synthetic rubber(s) or PVC must contain no 
natural rubber.  
 
II. surface : the gloves may be textured and non -slip – either partially or throughout – 
or smooth.  
III. format : 
 
a) surgical gloves – anatomical shape, with the thumb aligned with th e surface of the 
palm and index finger and either straight or curved towards the palm.  
b)  Non-surgical gloves – in the form of an open palm (ambidextrous) or 
anatomical shape.  
IV  sterilisation : sterile, non -sterile or to be sterilised.  
V use of powder or  other lubricant , i.e. presence or otherwise of powder.  
Article 6 – The gloves shall be referred to as "SURGICAL GLOVES" or "NON 
SURGICAL GLOVES" followed by the terms defined in Article 4.  Article 7 – The following general principles must be followed:  
I. Manufacturers of surgical and non -surgical gloves made of natural rubber, 
synthetic rubber, a mixture of natural and synthetic rubber, or PVC must observe the 
Boas Práticas de Fabricação – BFP (Good Manufacturing Practices).  
II. The use of surgical and non -surgical gloves made of natural rubber, synthetic 
rubber or a mixture of natural and synthetic rubber, or PVC must not pose a risk to users 
or patients.  
III. Surgical and non -surgical gloves made of natural rubber, synthetic rubber, a 
mixture of natural a nd synthetic rubber, or PVC must:  
 
a) be free of contaminants that may pose a risk to human health;  
b) undergo a prior safety assessment if they are to come into contact with human 
skin;  
c) contain only additives, odorants or colorants permitted by Brazili an 
Pharmacopeia or another equivalent international point of reference.  
IV.  Gloves that contain natural latex rubber must be processed in such a way as to 
reduce protein content.  
Article 8 – Surgical and non -surgical gloves made of natural rubber, synthet ic rubber, a 
mixture of natural and synthetic rubber, or PVC must meet the applicable Brazilian 
Standards.  
Article 9 – Surgical and non -surgical gloves made of natural rubber, synthetic rubber, a 
mixture of natural and synthetic rubber, or PVC must be manu factured, processed and 
used according to the BPF.  
Article 10 – Surgical and non -surgical gloves made of natural rubber, synthetic rubber, a 
mixture of natural and synthetic rubber, or PVC must be processed, packaged, stored and 
transported under condition s that do not provoke or increase the presence of physical, 
chemical or biological substances that may pose a risk to consumer health.  
Article 11 – Surgical and non -surgical gloves made of natural rubber, synthetic rubber, a 
mixture of natural and synthet ic rubber, or PVC must be identified by size in accordance 
with Brazilian standards.  
Article 12 – The ANVISA, by means of a Regulatory Instruction, shall lay down 
minimum identity and quality requirements for surgical and non -surgical gloves made of 
natura l rubber, synthetic rubber, a mixture of natural and synthetic rubber, or PVC.  
Article 13 – The labelling of the packaging of surgical and non -surgical gloves made of 
natural rubber, synthetic rubber, a mixture of natural and synthetic rubber, or PVC must:  
I. comply with the provisions of ANVISA RDC No  185 of 22  October 2001, 
"concerning the registration, amendment, renewal and cancellation of registration in the 
medical product register with the Agência Nacional de Vigilância Sanitária  – ANVISA 
(Brazilian Health Surveillance Agency)".  II. bear the following words prominently and legibly: "REPROCESSING 
PROHIBITED"  
III. The package label of surgical and non -surgical gloves containing natural latex 
rubber in any proportion must bear the following warning, prom inently and legibly:  
"THIS PRODUCT CONTAINS NATURAL RUBBER LATEX; ITS USE MAY 
CAUSE ALLERGIC REACTIONS IN PERSONS SENSITIVE TO LATEX."  
IV. IV  The labelling of surgical and non -surgical gloves made of natural rubber, 
synthetic rubber, a mixture of natural and synthetic rubber or PVC that are subject to 
health surveillance arrangements and that are to be sterilised must state the method of 
sterilisation recommendation by the manufacturer.  
V  Sterilised surgical and non -surgical gloves made of natural rubber , synthetic 
rubber, a mixture of natural and synthetic rubber or PVC, subject to health surveillance 
arrangements, must be individually packaged and labelled as left -hand or right -hand, as 
appropriate.  
VI  Note the provisions of point E: Labelling and Pack aging by means of a 
Regulatory Instruction, laying down minimum identity and quality requirements for 
surgical and non -surgical gloves made of natural rubber, synthetic rubber, a mixture of 
natural and synthetic rubber, or PVC, subject to health surveillan ce arrangements.  
Article 14 – The sampling plans, special inspection levels and acceptable quality levels 
applicable to the products subject this Resolution must be those laid down in Brazilian 
Standards, as laid down in the Regulatory Instruction laying d own minimum identity and 
quality requirements for surgical and non -surgical gloves made of natural rubber, 
synthetic rubber, a mixture of natural and synthetic rubber, or PVC, subject to health 
surveillance arrangements.  
Article 15 – Sterilised surgical an d non -surgical gloves must be packaged in packaging 
units (pairs of gloves) arranged so that they can be opened with the minimum difficulty, 
and must be packaged in such a way that the product is protected and can remain intact 
from its manufacture to its end use.  
Article 16 – Surgical and non -surgical gloves made of natural rubber, synthetic rubber, a 
mixture of natural and synthetic rubber, or PVC, subject to health surveillance 
arrangements, must be stored and transported under conditions that ensure tha t they are 
unaffected, in particular, by heat, humidity and light.  
Article 17 – Companies have 180 days in which to adjust to the provisions laid down in 
this Resolution.  
Article 18 – RDC ANVISA No  5 of 15 February 2008 is hereby repealed.  
Article 19 – Failure to fulfil the terms of this Resolution constitutes a health violation 
subject to the penalties set out in Law No 6437 of 20 August 1977 and to any other 
applicable measures.  
Article 20. This Resolution shall enter into force on the date of its publi cation.  
DIRCEU RAPOSO DE MELLO  
ANNEX 1.1 - REFERENCES  1.1 BRAZIL, Act No 8  078 of 11 September 1990, Consumer Protection Code, 
Diário Oficial da União  – DOU (Brazilian Official Gazette), Brasilia, 12 September 
1990, Supplement.  
1.2 Brazil, Interministerial  Order MS/MDIC Nº 692 of 8  April 2009, defining the 
implementation of technical cooperation for the quality and safety assurance of medical 
devices, subject to the health inspection arrangements, as laid down in the Technical 
Cooperation Agreement between the Health Ministry (MS) and the Ministry for 
Development, Industry and External Trade (MDIC).  
1.3 Brazil, ANVISA RDC No  56 of 6  April 2001. Technical Regulation laying down 
essential safety and effectiveness requirements applicable to the health products referred 
to in the Annex to this Resolution, DOU Brasília, Government, of 10  April 2001.  
1.4 Brazil, ANVISA RDC No  185 of 22 October 2001. Technical Regulation 
covering the registration, amendment, renewal and cancellation of the registration of 
medical pr oducts with the ANVISA, DOU Brasília, Government, of 6 November 2001.  
1.5 Brazil, RDC ANVISA No  156 of 11 August 2006, laying down provisions on the 
registration, labelling and processing of medical products and other provision.  
1.6 Brazil, ANVISA RDC No  207 of 17 November 2006, Technical Regulation 
covering the registration, amendment, renewal and cancellation of the registration of 
medical products with the ANVISA, DOU Brasília, Government, of 6 November 2001.  
1.7 Brazil, Associação Brasileira de Normas T écnicas  – ABNT ( Brazilian Technical 
Standards Association), NBR No  5426:1985, approving Sampling Plans and Procedures 
for the Inspection of Characteristics, 1985.  
1.8 Brazil, ANVISA RDC No  59 of 27 June 2000. Technical Resolution laying down 
essential safe ty and effectiveness requirements applicable to health products, compliance 
with the requirements of must observe the Boas Práticas de Fabricação – BPF (Good 
Manufacturing Practices), DOU Brasília, Government, of 29 June 2000.  
1.9 Brazil, Associação Brasil eira de Normas Técnicas  – ABNT (Brazilian Technical 
Standards Association), NBR No  11193: -1, approving the Brazilian standard for single -
use medical examination gloves, Part 1:. Specifications for gloves made from latex 
rubber or rubber solution.  
 
1.10 INTERNATIONAL STANDARDIZATION ORGANIZATION - ISO 11193 -
2:2006 Single -use medical examination gloves, Part 2:  Specification for gloves made 
from poly(vinyl chloride).  
1.11 INTERNATIONAL STANDARDIZATION ORGANIZATION – ISO 
10282:2005(E) Single sterile rubber sur gical gloves – Specification, 2002, Technical 
Corrigendum 2005.  
  
1.12 INTERNATIONAL STANDARDIZATION ORGANIZATION ISO 37:2008 
Rubber, vulcanize or thermoplastic – Determination of tensile stress -strain properties, 
2005, Technical Corrigendum.  1.13 Regulato ry Standard 6 – No 6 Individual Protection Equipment, approved by 
Order No  3 214 of 8  June 1978.  
1.14 European Commission, Health & Consumer Protection Directorate -General, 
Scientific Committee on Medical Products and Medical Devices, Opinion on natural 
rubber latex;  27 June 2000.  
1.15 Brazil, Ministry of Labour and Employment Order No  121 of 30  September 2009, 
laying down technical standards for testing and mandatory requirements for individual 
protection equipment, forming part of Annex I of NR -6. DOU of 2 October 2009 - 
Section 1, p 80 and 82.