TECHNICAL DATA SHEET F550CS
USFDA/NIOSH N95 Approved Respirator DUCKBILL Mask non-sterile with continuous loop headband
|Filter layers:||5 layers of non-woven fiber containing filter web in the middle|
|Outer layer:||Polypropylene Spunbond|
|Filter Media:||Polypropylene Meltblown|
|Inner layer:||Polypropylene Spunbond|
|Elastic bands:||Synthetic elastic (no latex material), suitable length for secure fit|
|Nose-piece:||Combination of zinc wires and embedded polyethylene inside of layers|
US FDA APROVAL Class II / ISO 9001:2015 / NIOSH APPROVAL: N95 TC-84A-7504
FDA Classification panel: General and Plastic Surgery
Bacterial Filtration Efficiency (BFE): > 99 % with 3.0μm, bio-aerosol particles
Particulate Filtration Efficiency (PFE): > 95% for particles at 0.3 μm
Differential Pressure (DP): 10 mm of H2O/cm2
Breathability (DP): Ezy Breathe Technology
Fluid Resistance: Resists Synthetic Blood @ 160mmHg of pressure
Textile Flammability: Class I – Normal Flame Spread
Skin Irritation: No skin irritant
Skin Sensitization: No skin sensitizer
Cytotoxicity test: Non-cytotoxic under conditions of study
FIT ASSESSMENT TEST: Fit test required
Sizes: One Size, previous test results fit approx.90% of adult population
Storage: Store under cool, clean, and dry conditions. Avoid excessive heat (over 40°C or 104°F)
Shelf Life: As a guide, 5 years from manufacture date
Intended Use: Single Use Only
Country of Origin: Singapore, Pasture Pharma, Pte. Ltd.
Country of Manufacture: Taiwan, the model F550CS filtering face-piece respirator has been manufactured for Pasture Pharma Pte. Ltd. under approval TC-84A-7504
Indication for use: Pasture F550CS is a NIOSH certified N95 respirator, and is indicated to be used by healthcare personnel during procedures to protect both the patients and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
- An N95 designation indicates that the filtration is more than 95% (using NaCl particles with a diameter of 0.3μm). The masks are not resistant to oils, and do not filter out particles that came into contact with oils.
- All tests were conducted in accordance with US-FDA / NIOSH and CDC / ISO 9001:2015 Standards.
- The mask covers from the upper part of the nose to below the chin; the mask protects against pollution, germs and allergens; the mask has no sharp edges and is free from burrs with smooth finish; the mask fibers are non-glass fibers; the mask is latex free.