I/ ASTM F2100-19 for the US market

For products belonging to the medical equipment group, specifically medical masks, gas masks, epidemic prevention kits… that want to be exported to the markets of developed countries such as the US and EU, it is necessary to ensure Ensure standard certificates comply with regulations.

is proud to be a manufacturer of medical masks that meets FDA certification and ASTM F2100-19 Level 2, Level 3 standards and exports to the US market.

II/ Overview of ASTM F2100 standard

ASTM F2100 is a standard of the American Institute of Standards and Technology (ASTM International) for medical masks used in medical procedures and infection prevention.

The levels of the ASTM F2100 standard are divided into three levels, evaluating the filtering and protective ability of masks as follows:

Level 1: This is the lowest level in the ASTM F2100 standard, with the ability to filter at least 95% of particles larger than or equal to 0.1 microns. Level 1 masks are often used in situations where there is frequent contact with patients who are not infected with viruses or bacteria.
Level 2: This level is capable of filtering at least 98% of particles greater than or equal to 0.1 microns, and also provides protection for users against the risk of exposure to patients infected with viruses or bacteria. Level 2 masks are commonly used in hospitals, clinics, laboratories and other medical situations.
Level 3: This is the highest level in the ASTM F2100 standard, with the ability to filter at least 98% of particles greater than or equal to 0.1 microns and provide the highest protection for users. Level 3 masks are often used in special medical situations such as surgery and dangerous infectious diseases.

III/ Kim Sora medical masks meet export quality to the US market:

To meet the strict standards of the US market and the desire to bring products to the US, Kim Sora has made efforts to develop products and test them to meet ASTM F2100-19 Level 2, level 3 standards.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

In addition, Kim Sora medical masks are certified:

ISO 9001:2015: is a standard system for product quality management; recognized worldwide. Any business whose products meet the standards set by ISO; will be granted ISO 9001 certificate. When obtaining ISO 9001 certificate; proving that the enterprise has an effective quality management system and meets common international standards.
ISO 13485:2016 – is a standard for management systems applied in the field of manufacturing and trading of tools; medical supplies.
FDA: is to monitor and evaluate food quality; Whether the pharmaceutical product meets the criteria for import into the US?
CE: is a document indicating that the product has met health protection standards; safety and environmental protection according to European Union (EU) law and will be circulated in the European Economic Area (EEA).

As a manufacturer operating in the international market, the main export markets are Japan, Taiwan, Korea, Switzerland, America…. we hope to bring consumers quality products. Quality according to “Japanese standards – European style – Affordable prices”.

In addition to export, the Kim Sora brand distributes and wholesales medical masks nationwide with a price policy and commitment to leading prestigious quality nationwide.

With quality products and reasonable prices, Kim Sora is a reliable address and trusted by many customers. Please contact this distributor for advice and to order today.