Safety Alert for Top Quality - Latex Gloves for Non-Surgical Procedure, with Powder, Registration 80495510001, Extra-small (PP) sizes; Mean (M); Large (G). Lots: Annex I

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 did not meet the "elongation of original rupture" requirement of the INMETRO Ordinance nº332, of June 26, 2012. The health services that have the product in stock must segregate the samples so that the holder of the registration proceed with the collection.//// UPDATE ON 03/15/2015: The OCP informed Anvisa that on February 17, 2012, the suspension of the authorization for the use of the Conformity Identification Seal (Ref 00267- 2) .//// UPDATE 03/22/2016: Field Action completed on 1/8/2016, with collection and destruction of the products.