US FDA 510K Approved Surgical Mask Non-Sterile with 3-D Design
Indication for Use:
- To be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
FDA 510(k): K141875
Country of Origin: Singapore
Country of Manufacture: Taiwan
| Material Description | |
| Outer Layer: | Polypropylene Thermobond |
| Filter Media: | Polypropylene Meltblown |
| Inner Layer: | Polypropylene and Polyethylene bi-component |
| Elastic Bands: | Earloops, Synthetic elastic (no latex material) |
| Nose-piece: | Combination of zinc wires and embedded polyethylene |
| Color: | White |
| Product specifications | |
| Mask Style: | Flat Pleated 3-D |
| Size: | One Universal Size |
| FIT ASSESSMENT TEST: | No Fit Test Required |
| Bacterial Filtration Efficiency (BFE): | ≥ 99% with 3.0μm, bio-aerosol particles |
| Particulate Filtration Efficiency (PFE): | ≥ 99% for particles at 0.1μm |
| Differential Pressure (DP): | 3.33mm H2O/cm2 |
| Breathability (DP): | Ezy-Breathe Technology |
| Fluid Resistance | Resists Synthetic Blood @ 80mm 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 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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