Background: Products such as male condoms, which are made from natural rubber, must undergo rigorous quality control before being made available to the public. In Brazil, condoms, both domestic and imported, are compulsorily certified and their production is governed by strict criteria, which cover everything from the quality of the latex to the specifications for primary packaging, packaging for consumption and transportation. However, although the certification process assesses the production and the product in detail at the end of manufacturing, it does not address the issue of after-sales service in the various establishments, issues typical of Sanitary Surveillance actions.
Methods: Three batches of male condoms from different brands, purchased from digital marketplaces, were evaluated. The samples were anonymously identified as (Sample A), (Sample B), and (Sample C). A total of 288 units were purchased per batch. Based on the number of units purchased per batch, the inflation test was performed, which assesses resistance by determining the volumetric capacity and burst pressure. For the inflation test, we tested 200 units per brand, according to the criteria established in the Resolution of the National Sanitary Surveillance Agency No. RDC 554/2021. In one of the samples, it was necessary to perform the aging test, sample stability, before the insuflation test (Sample B).
Results and Conclusion: All brands met the criteria established in the Resolution of the National Sanitary Surveillance Agency No. RDC 554/2021 for the inflation test, which allows up to seven non-compliant units; however, non-conformities were found in all of them. We conclude that, in addition to certification, there is a need to monitor this product in view of the health risk observed, and a systematic and active techno vigilance system can provide a new dimension to the National Sanitary Surveillance System in monitoring this product in digital markets.