The aim of this document is to provide useful information for all subjects involved in the developing of surgical masks as medical devices in the effort to fight against the Covid-19 pandemic.
This document presents a market- based state of the art review in the field of manufacturing and testing of surgical face masks.
Information has been collected on the U.S.-FDA 510k database and statistically analysed in order to find out the actual best practices as regards face masks, their manufacturing development (materials and characteristics) and their testing for safety and efficacy.
This is a first exploit of the on-going research in progress at Eurofins Biolab S.r.l. in these field, while further deepening on this topic is under development.
Method
The 510k submission summary reports related to the period January 2010 – December 2019 (last submission date) have been exported from the database in CSV format and converted in an Excel file.
1 Constituent Materials
The component materials of each surgical face mask have been identified from the summary reports in order to assess which is the commonly used material for this medical device. Information about component materials of the following mask parts has been extracted from the submission report:
- inner layer (in contact with face skin);
- middle layer (which typically is the components that ensures the filtering properties);
- outer layer;
- era loops or tips;
- nose clip (if present);
The occurrence of material combination for the different device parts has been calculated in absolute and percentage values.
2 Performed Test
Information about performed test has been collected in the Excel file. Conversion factors between U.S.A. typical measure units and European typical measure units have been applied, in order to be able to compare the retrieved test results with the requirement of EN 14683:2019 [1] described in Figure 1. The following conversions have been performed:
- As regards the Fluid Resistance Performance Test, the results have been converted from mmHg to kPa;
- As regard the Differential Pressure test, the results have been converted from
mmH2O/cm2
to Pa/cm2.
The collected data have been analyzed and compared to materials combinations to identify possible correlations.
3 Biocompatibility
The 510k submission summaries have been analyzed to inquire if all submitted face masks meet the requirement of ISO 10993-1:2018, as described in §4.
4 Further information
Information about sterilization and classification of this medical device according to Directive 93/42/EEC1 [6] has been collected from the 510k submission summaries.
