US FDA/NIOSH N95 Approved Respirator CONE-SHAPED Non-Sterile with Continuous Loop Headband
Indication for Use:
- To be 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.
FDA 510(k): K020474
NIOSH APPROVAL: N95 TC-84A-5411 (For PM 15)
NIOSH APPROVAL: N95 TC-84A-5463 (For PM 15S)
NIOSH APPROVAL: N95 TC-84A-5411 (For PM 15)
NIOSH APPROVAL: N95 TC-84A-5463 (For PM 15S)
Country of Origin: Singapore
Country of Manufacture: China
| MATERIAL DESCRIPTION | |
| Outer Layer: | Polyester |
| Filter Media: | Meltblown |
| Inner Layer: | Polyester |
| Elastic Bands: | Spandex (Ultrasonic welded) |
| Nose-piece: | Aluminium |
| Nose-cushion: | High density urethane foam |
| Color: | White or Blue outer layer |
| PRODUCT SPECIFICATIONS | |
| Size: | Two Sizes (Medium/Large and Small) |
| FIT ASSESSMENT TEST: | Fit test required |
| Bacterial Filtration Efficiency (BFE): | > 99% with 3.0μm, bio-aerosol particles |
| Particulate Filtration Efficiency (PFE): | > 95% for particles at 0.3μm |
| Differential Pressure (DP): | 10mm of H2O/cm2 |
| Breathability (DP): | Ezy-Breathe Technology |
| Fluid Resistance: | Resists Synthetic Blood @ 160mm 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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