FDA 510K Mask Tests

Surgical masks cover the nose and mouth of the user and provide physical protection against liquids and particles. With the legal regulation numbered 21 CFR 807 prepared by the American Food and Drug Administration (FDA), the 510 (K) application, which regulates various product conformity tests, has been put into effect. Surgical masks referred to in this embodiment include masks defined as surgical, laser, isolation, dental, or medical procedure masks with or without a face shield.

Filtration efficiency is important in FDA 510K mask tests. Masks should be evaluated in terms of both particle filtration efficiency and bacterial filtration efficiency.

When determining the particle filtration efficiency, a particle loading study using 0.1 micron polystyrene latex spheres is recommended. The use of latex spheres ensures proper testing to evaluate submicron efficiency performance. These tests are based on the ASTM F1215-89 standard designed by the American Society for Testing and Materials (ASTM) (Test method for determining the initial efficiency of a flat sheet filter media in an airflow using ASTM F1215 Latex balls).

While determining the bacterial filtration efficiency, the ability of the mask material to prevent the passage of aerosolized bacteria is determined. Bacterial filtration efficiency is expressed as the percentage of the amount that does not exceed the mask material at a given aerosol flow rate. These tests are based on the ASTM F2101-01 standard, also designed by the American Society of Testing and Materials (ASTM) (ASTM F2101-01 is the standard test method for evaluating the bacterial filtration efficiency of medical face mask materials using Staphylococcus aureus biological aerosol). These tests also comply with the MIL M36954C standard for determining bacterial penetration (aerosol filtration) (MIL M36954C Mask, surgical, disposable).

FDA 510K mask tests are carried out to prove that a new mask design is equivalent to other masks available on the market. These analytical tests are aimed at determining how safe and effective the new mask is. In this context, chemical characterization, material compatibility, biocompatibility, impurity definitions, method validity and a number of mandatory tests are applied.

With the experience gained over many years, our organization also provides FDA 510K Mask testing services to the demanding enterprises within the framework of laboratory services of materials with a trained and expert staff.