DETAILED INFORMATION AND INSTRUCTIONS FOR USE
| Product Name | Fobivi Regular Face Mask |
| Product Model | FBV96 |
| Structure | 4 layers and flat-pleated Face masks. |
| Mask Style | Flat Pleated |
| Contact Duration | Limited – Less than 24 hours |
| Confroming to | QKR |
| Inner layer | PP nonwoven fabric: Spun bond polypropylene 20-25 gsm |
| 1st Middle layer | PP nonwoven fabric: Spun bond polypropylene 20-25 gsm |
| 2nd Middle layer | Meltblown polypropylene filter: Melt blown polypropylene filter 20-25 gsm |
| Outer layer | PP nonwoven fabric, flat & waterproofing:
Spun bond polypropylene 20-20 gsm |
| Nose clip | Galvanized wire coated with polyethylene or plastic |
| Ear loops/Ties | Spandex – Not made from natural rubber latex
Spandex Circle Earloop/ Spandex Nonwoven Earloop/ Ties-on |
| Dimension | Length: 17.5 cm ±1 cm, 19.5 cm ±1 cm, 14 cm ±1 cm, 15 cm ±1 cm |
| Width: 9.5 cm ±1 cm | |
| Color | Blue/ White/ Black |
| Use | Single Use, Disposable |
| Primary packaging | 10 pcs in a bag or 1 pcs in a bag |
| Secondary packaging | 5 bags in a case or 50 pcs in a case (If application) |
| Finished packaging | 50 cases in a carton box/Others |
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Test report
Product |
Testing Standard |
Test code |
Test type |
Lab |
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 |
BFE | Bureau Veritas | |
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 |
BFE |
Nelson |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 |
BFE |
SGS |
|
| Fobivi Face Mask (4 Layers) |
ASTM F2100 |
Delta P |
Nelson |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Differential Pressure |
Bureau Veritas |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Differential Pressure |
SGS |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Flammability |
Bureau Veritas |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Flammability |
Nelson |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Flammability |
SGS |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | PFE |
Bureau Veritas |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | PFE | + 0.1 micron |
Nelson |
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | PFE |
SGS |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Synthetic Blood Resistance |
Bureau Veritas |
|
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Synthetic Blood Resistance | 80 mmHg |
Nelson |
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Synthetic Blood Resistance | 120 mmHg |
Nelson |
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Synthetic Blood Resistance | 160 mmHg |
Nelson |
|
Fobivi Face Mask (4 Layers) |
ASTM F2100 | Synthetic Blood Resistance | 160 mmHg (Level 3) |
SGS |
|
Fobivi Face Mask (4 Layers) |
ASTM F2101 | PFE | + 0.3 micron |
Nelson |
|
Fobivi Face Mask (4 Layers) |
EN 14683 | BFE | Bureau Veritas | |
| Fobivi Face Mask (4 Layers) | EN 14683 | BFE |
Nelson |
|
|
Fobivi Face Mask (4 Layers) |
EN 14683 | BFE | SGS | |
| Fobivi Face Mask (4 Layers) | EN 14683 | Breathability |
SGS |
|
|
Fobivi Face Mask (4 Layers) |
EN 14683 | Delta P | Nelson | |
|
Fobivi Face Mask (4 Layers) |
EN 14683 | Differential Pressure |
Bureau Veritas |
|
| Fobivi Face Mask (4 Layers) | EN 14683 | Synthetic Blood Resistance | Type IIR |
SGS |
|
Fobivi Face Mask (4 Layers) |
EN 14683 | Synthetic Blood Resistance | Type IIR | Bureau Veritas |
| Fobivi Face Mask (4 Layers) | EN 14683 | Synthetic Blood Resistance | 80 mmHg |
Nelson |
|
Fobivi Face Mask (4 Layers) |
EN 14683 | Synthetic Blood Resistance | 120 mmHg | Nelson |
| Fobivi Face Mask (4 Layers) | EN 14683 | Synthetic Blood Resistance | 160 mmHg |
Nelson |
Characteristic
Standard |
FOBIVI mask |
|
Resistance to penetration by synthetic blood ASTM F1862 |
Pass Level 3: 160 mm Hg = high pressure irrigation |
|
Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2299 |
~ 96% |
| Bacterial Filtration Efficiency ASTM F2101 |
~ 96% |
|
Differential Pressure (Delta P) MIL-M-36954C |
<60 PA/cm2 |
| Flammability 16 CFR 1610 |
Pass Class 1 |
|
Biocompatibility ISO 10993-5 and ISO 10993-10 |
Under the conditions of the study, the device is non-irritated. |
| Cytotoxicity ISO 10993-5 |
Under the conditions of the study, the device is non-cytotoxic. |
|
Skin Sensitization test ISO 10993-10 |
Under the conditions of the study, the device is non-sensitizing. |
| Skin Irritation test ISO 10993-10 |
Under the conditions of the study, the device is non-irritating. |
|
Indication for use |
The Regular Face Masks are intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.This is a single use, disposable device provided sterile/non-sterile. |
|
Expiry date |
3 years.
Note: End of shelf life is marked on the product packaging. Before initial use, always check that the device is within the stated shelf life (use by date). |
|
Storage |
Surgical mask should be stored in clean, dry conditions within the temperature range: 25 +- 5C with a maximum relative humidity < 80%. |
|
Transportation |
When storing or transporting this device use original packaging provided. |
Basic Item No.# |
Short Description |
|
FBV96-01-NS-19.5 |
Fobivi Regular Face Mask, 4 layers, Non-sterile. Dimension: Length: 19.5 cm ±1, Width: 9.5 cm ±1 cm |
| FBV96-01-NS-17.5 |
Fobivi Regular Face Mask, 4 layers, Non-sterile. Dimension: Length: 17.5 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-NS-15 |
Fobivi Regular Face Mask, 4 layers, Non-sterile. Dimension: Length: 15 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-NS-14 |
Fobivi Regular l Face Mask, 4 layers, Non-sterile. Dimension: Length: 14 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-19.5 |
Fobivi Regular Face Mask, 4 layers, Sterile. Dimension: Length: 19.5 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-17.5 |
Fobivi Regular Face Mask, 4 layers, Sterile. Dimension: Length: 17.5 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-15 |
Fobivi Regular Face Mask, 4 layers, Sterile. Dimension: Length: 15 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-14 |
Fobivi Regular l Face Mask, 4 layers, Sterile. Dimension: Length: 14 cm ±1, Width: 9.5 cm ±1 cm |
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