Safety Alert for Glove for Non-Surgical Procedure with powder - Registration No. 10330660014, Sizes PP, P, M, G

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.

The semi-annual maintenance tests indicated that the sample analyzed does not meet the microbiological requirements of INMETRO Ordinance no. 322 of June 26, 2012. The health services that have the product in stock must segregate the samples so that the registry holder can proceed with the collection. ////// UPDATE - 04/17/2014 - The company informs that considering that gloves tested are Gloves for Non-Surgical Procedures, and that, due to their own instructions for use, Gloves for Non-Surgical Procedures Descarpack are not used in invasive procedures where controlled microbiological requirements are paramount. According to the American Pharmacopoeia, USP, non-sterile products are used in regions of the human body that are rich in bacterial flora and have physical or immunological barriers to infection. Examples cited are the oral cavity, skin, nasopharynx, rectum among others, which harbor a high and diversified viable microbial population. Recent studies carried out from the Human Microbiome Project underline the enormous size and diversity of human-associated bacterial populations. A healthy adult has a bacterial population of approximately 1014 bacteria, a number that exceeds the subject's own cells by a factor of 10. In addition, according to the results of test reports MIC-L-241861/1/14 (test) and 244561/1/14 (counter-proof) issued by the Instituto Falcão Bauer da Qualidade (IFBQ), pathogenic microorganisms were not found in the gloves. ///// UPDATE - 08/13/2014 - The company sent a report of completion of the field action, all customers were informed of the action of collection, and collected 135,388 cartridges of the lots involved in this field action.) / /// UPDATE 10/20/2014 - The IFBQ revoked the suspension of the Authorization for the use of the Conformity Identification Seal, in order to carry out all necessary actions and approval in the tests provided for in the Conformity Assessment Regulations, carried out in samples produced after corrective actions.