Argentina’s National Administration of Medicines, Food and Medical Technology (ANMAT) controls the use of face masks. ANMAT requires that the face mask must provide a physical and fluid barrier to protect the user again coronavirus. The face mask must be made of surgical fabrics, have two, three and up to four layers, enough space for the wearer to be breath and be “splash resistance”.
Classification of Face Masks:
The masks are classified by the Ministry of Health, as medical devices: Class I (the lowest risk).
Based on the following evaluation of the Qualitative features, the Masks are Divided into three Types.
- Filtering efficiency against bacteria: expressed as a percentage, defines the filter capacity of masks. The higher the value, the greater the filter capacity.
- Breath resistance: Defines shortness of breath through the mask. At a lower value, the less the shortness of breath.
- Splash Resistance (“Splashes”– Defines the resistance against splashes that may arise. The higher the value, the greater the protection.
- Type 1 Basic (room care) – 2 layers.
- Type 2 Class I (standard performance) – 3 layers.
- Type 3 Class II (high performance performance or high risk of infection due to duration or intensity of intervention) – 3 or 4 layers.
The fabric must be made of non-woven polypropylene (PP) fabric. Fabric Requirements are divided into three types.
- Type 1: two layers (SBPP + MB – Minimum Weight: 18g + 25g).
- Type 2 and 3: three or four layers (SBPP + MB + SBPP – Minimum Weight: 18g + 25g + 25g).
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
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