FDA Standard 510(K) Three Layers Blue Disposable Earloop Face Mask
Disposable Face Mask (ASTM F2100 Level-3)
| Layer | three layers |
| Style | flat pleated, earloop, adjustable nose clip |
| ASTM F2100 Level | Level-3 |
| Color | blue |
| Sterility | non-sterile |
| Size | 17.5x9.5cm |
| Packaging | 50pcs/box, 40boxes/carton or 10pcs/polybag, 10bags/carton |
| Applications | operation, dental clinic, |
| OTC use | Yes |
Product Test Data:
| ASTM F2100 Level | Level-3 |
| Biocompatibility | ISO10993 |
|
Fluid Resistance Performance ASTM F1862 |
32 out of 32 pass at 160 mmHg |
|
Particulate Filtration Efficiency ASTM F2299 |
98.98% |
|
Bacterial Filtration Efficiency ASTM F2101 |
99.9% |
|
Differential Pressure(Delta P) EN 14683 Annex C |
5.54mmH2O/cm2 |
About Us:
Hubei TDL Group is made of Hubei Orient International Trading Corporation and Ammex-weida(Hubei) Health and Safety products Co.,Ltd. We specilize in the design,manufacturing and sales of disposable medical products and PPE products for more than 20 years.
We established in 2003,covering 65,000 square meters. We are a group of more than 500 individuals. Ammex-weida is equipped with a medical and industrial laboratory in class 10000, clean room workshops in class 100000 for sterile medical devices and all kinds of disposable products.
Our group has more than 20 individuals for QC quality control, laboratory and inspection.Our laboratory could do tests for face masks such as particulate filtration efficiency, differential pressure, Synthetic blood penetration,Tensile test for earloop,flammability test,microbial cleanliness,splash resistance,sterile test, ethylene oxide residue etc.And also we could do tests for coveralls such as hydro-static pressure, Repellency by liquids, Resistance to Penetration by liquids,Surface Resistance, Resistance to Ignition,filtering efficiency,Puncture Resistance,Tensile strength,static decay period,sterile test, ethylene oxide residue etc.
We utilizes a complete quality management system ISO9001, ISO13485. We care about human rights and we are certified by human right agency of SEDEX. Ammex-weida has medical device license for class I and II. Our products are certified with CE, FDA, UKCA. Our medical face masks passed through Nelson's test. Our medical face masks are conform to EN14683 type II and type IIR for Europe market, ASTM level 3 510K for North America and the national standard YY0469 and YY0969 for China market. Our category III protective coveralls are complied with new European PPE Regulations (EU)2016/425. They are classified to type 3/4/5/6 and 3B/4B/5B/6B.
Our Product Lines:
1. Face mask: disposable nonwoven face mask, surgical facemask, active carbon face mask, dust mask, N95 mask, paper mask, etc.
2. Surgical gown: surgical gown, PP/PE gown, isolation gown, SMS surgical gown, sterile surgical gown, patient gown, etc.
3. Coverall:disposable PP coverall, PP/PE coverall, SMS coverall , Microporous coverall (with/without hood, with/without boots, any color.)
4. Lab coat: disposable lab coat, PP lab coat, SMS lab coat, Microporous lab coat, vistor coat, PP/PE/Tyvek apron.
5. Caps: doctor caps, bouffant caps, round caps, clip caps, non woven caps
6. Sleeve/shoe cover: PP sleeve cover, pe sleeve cover, SMS sleeve cover, Microporous sleeve cover, non skid shoe cover, PE/CPE shoe cover
7. Beauty Products- Nonwoven kimono, mantle, hair band, slipper, PE shower cap and so on.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.