Alerta De Seguridad para GLOVE FOR NON-SURGICAL PROCEDURE WITH LAGROTTA AZZURRA POWDER - Registered at Anvisa dob the number 80044540022 - all batches.

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.

According to RDC 05, of February 15, 2008, the certification of gloves is a prerequisite for its commercialization. Anvisa is following the actions. #### 11/01/2011 - Anvisa published Resolution RE no. 94, of 10/01/2011, in the DOU no. 7 of 11/01/2011, prohibiting the importation and commercialization of the product. http://www.in.gov.br/servlet/INPDFViewer?jornal=1&pagina;=53&data;=11/01/2011&captchafield;=firistAccess.####14/09/2011 - OCP ICEPEX proceeds Certification for this model of glove, revoking the effects of this Sanitary Alert. #### 10/10/2011 - Anvisa revokes RE 94, through the publication of RE No. 4,528, of 10/6/2011. There is no restriction on the use of products from this company for lots manufactured after the date of certification.