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.

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.

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.