US FDA/NIOSH N95 Approved Respirator DUCKBILL Non-Sterile with Adjustable Clip
Indication for Use:
- Used by the healthcare personnel during procedures to protect both the patients and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
- F550CS is the same respirator as the F550S, except F550CS contains an adjustable buckle on the headband.
FDA 510(k): K141876
NIOSH APPROVAL: N95 TC-84A-7504
NIOSH APPROVAL: N95 TC-84A-7504
Country of Origin: Singapore
Country of Manufacture: Taiwan
| Material Description | |
| 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 |
| Nose-cushion: | Polypropylene |
| Adjustable Buckle: | Acrylonitrile Butadiene Styrene |
| Color: | White |
| Product specifications | |
| Size: | One Universal Size |
| FIT ASSESSMENT TEST: | Fit test required |
| Bacterial Filtration Efficiency (BFE): | > 99% at 3.0μm, bio-aerosol particles |
| Particulate Filtration Efficiency (PFE): | > 95% for particles at 0.3μm |
| Differential Pressure (DP): | 10mm H2O/cm2 |
| Breathability (DP): | Ezy-Breathe Technology |
| Fluid Resistance: | Resists Synthetic Blood @ 120mm Hg 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 |
| Manufacturing Facilities: | ISO 13485 / ISO 9001:2015 |
| Intended Use: | Non-sterile, Single Use Only |
| 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 |
NOTE 1 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.
NOTE 2 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
NOTE 2 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
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