US FDA 510K Approved Mask Non-Sterile with Tie-On Bands
Indication for Use:
- To be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
- For use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids.
- The mask is a single use, disposable device, provided non-sterile.
FDA 510(k): K152197
Country of Origin: Singapore
Country of Manufacture: China
| MATERIAL DESCRIPTION | |
| Outer Layer: | Polypropylene |
| Filter Media: | Polypropylene Meltblown |
| Inner Layer: | Polypropylene |
| Tie Back: | Polypropylene |
| Nose-piece: | PE inside of layers |
| Color: | Blue, Green, White |
| PRODUCT SPECIFICATIONS | |
| Size: | Adult Size (175 x 95mm) |
| Bacterial Filtration Efficiency (BFE): | > 99% |
| 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 |
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