American Medical Distribution

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American Medical Distribution
Our factory can now produce over one million high quality, ISO 9001-2000 certified surgical masks per day. We can increase production up to 3.5 million per day as required.

Attached please find the Nelson Laboratories test report for the masks made in our factory.
There are two pages for the 3 ply, non-woven masks and the factory TUV Certificate. The pages are difficult to read so I will go over each page in writing:

Page 1. This is the actual Nelson Laboratories summary test page for our factory's masks. It states that the mask material is made of JS polypropylene fiber that is less than 0.4 microns in diameter, and that the mask will filter airborne particles of 0.3 microns.

It further states the details of the manufacturing process and equipment, the testing method (Sodium Flame - same as NIOSH) and the physical properties of the mask material and density of 20g/M2 (20 grams per square meter).

The actual test results show the mask will filter out 98.5% of 0.11 micron to 0.13-micron particles. By comparison, N95 standards require filtering only 95% of 0.3 microns or larger particles.

Page 2. Table 1 shows the results of a different test for 5 masks of 3 ply non-woven material. The five masks filter out an average of 99.7% of 0.27-micron particles.

Page 3. TUV Certificate - This is a VERY important document. It indicates the level of quality of the products the factory produces. There are only 12,000 factories around the world with a TUV certificate, 1,200 of them are in China and 443 are in the USA.

Our factory not only has the TUV certificate, but it has also successfully completed the extremely difficult task of being formally certified in additional quality organizations in Europe, Japan, and the United States:
ISO 9001:2000 - International Standards Organization - A guarantee of quality in design and manufacturing medical devices.
EN ISO 901:2000 - European Standards Quality Control
JIS Q 9001:2000 - Japanese International Quality Standards Organization
ANSI/ASQC Q9001: 2000 - American National Standards Institute - The American Quality Standards Organization.

Only a hundred factories around the world have this level of quality certification. Only one of the USA manufacturers who make N95 standards masks has even a single a quality certification - and that is a 9000:1996 cert.

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