Alerta De Seguridad para Trade name: LATEX GLOVE FOR NON-SURGICAL PROCEDURE Technical name: LATEX GLOVE FOR NON-SURGICAL PROCEDURE Registration number ANVISA: 80680560001 Risk class: I Affected model: NON-SURGICAL PROCEDURE GLOVE WITH SUPERLATEXX POWDER: PP; P; M; G. Series numbers affected: 12L2785M; 11L2786S; 11L2787S; 12L2787M; 12L2788XS; 11L2788S; 12L2788S; 12L2788M; 12L2788L.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por X&X; DENTAL IMPORTAÇÃO E EXPORTAÇÃO – LTDA; LATEXX MANUFACTURING SDN BHD.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    A X & X; DENTAL GUIDELINES USERS AND / OR PATIENTS THAT IN ANY CASE OF INTERCONNECTION TO THE USE OF THE PRODUCT LATEX GLOVE FOR NON-SURGICAL PROCEDURE WITH SUPERLATEXX BRAND POWDER WHICH CONTACT THE COMPANY BY THE TELEPHONE (27) 3721-9930 OR BY THE MEDSAFE E-MAIL @ MEDSAFE.NET.BR ### UPDATED ON 12/28/2017: Certificate 8356/14 was canceled on 10/17/2017, "due to non-compliance with the certification maintenance stage", according to the CANCELLATION OF THE CERTIFICATE issued by OCP accredited by INMETRO. The company that holds the affected product registration is responsible for timely contacting its customers in order to ensure the effectiveness of the ongoing Field Action. Regarding the Glove Certification Process, we highlight: 1. The Glove Certification is compulsory, according to health regulations - RDC 55/2011, which establishes the new minimum requirements for identity and quality for surgical gloves and gloves for non-surgical rubber procedures natural rubber, synthetic rubber, natural and synthetic rubbers and polyvinyl chloride blend, under sanitary surveillance, which replaced the RDC Collegiate Board Resolution No. 05, approved by the National Health Surveillance Agency - Anvisa, on February 15, 2008; 2. THE PORTAL INMETRO 332/2012, among others, (i). Approved the revision of the Conformity Assessment Requirements for Surgical Gloves and Non - Surgical Procedure of Natural Rubber, Synthetic Rubber and Synthetic Rubber Blends; It established, under the Brazilian System of Conformity Assessment (SBAC), that the compulsory certification for Surgical Gloves and Non - Surgical Procedure of Natural Rubber and Natural and Synthetic Rubber Mixtures is maintained; Determined that, as of the publication of this Ordinance, Surgical Gloves and Non-Surgical Procedure of Natural Rubber, Synthetic Rubber and Synthetic Rubber Mixtures shall comply with the technical requirements established in RDC No. 55 of November 4, 2011, of Anvisa. (Iv). It determined that surgical and non-surgical gloves of synthetic rubber and polyvinyl chloride are exempt from compulsory certification under the SBAC, as established in the Sole Paragraph of Article 7 of RDC No. 55, dated November 4, 2011, of Anvisa; (v). Determined that the supervision of compliance with the provisions contained in this Order, throughout the national territory, will be in charge of Inmetro and the entities under public law with which it has agreed.
  • Causa
    The product manufacturer, latexx manufacturing, used to produce gloves a plant of their fabril park that was not consisting of the scope of the certification.
  • Acción
    Field Action Code AC01 / 2017 triggered under the responsibility of company X & X; DENTAL IMPORTATION AND EXPORT - LTDA. The company will make payment. #### UPDATED ON 04/02/2018: The judicial decision of the Federal Regional Court of the 2nd Region, contained in Process No. 0024487-66.2017.4.02.5005 granted the application for urgent protection, removing the need that the company holding the registration holds a specific certificate for the shed that produced the goods, thus authorizing the sale of the gloves, "mainly because of the tests carried out, by means of which the quality and safety of the products have been certified." ###