DETAILED INFORMATION AND INSTRUCTIONS FOR USE
| Product Name | Fobivi Surgical Face Mask (3 Layers) |
|
Product Model |
FBV96 |
|
Structure |
3 layers and flat-pleated Face masks. |
|
Mask Style |
Flat Pleated |
|
Contact Duration |
Limited – Less than 24 hours |
|
Conforming to |
FXX (21 CFR 878.4040) |
|
Inner layer |
PP nonwoven fabric: Spun bond polypropylene 20-30 gsm |
|
Middle layer |
Meltblown polypropylene filter: Melt blown polypropylene filter 20÷40 gsm |
|
Outer layer |
PP nonwoven fabric, flat & waterproofing:
Spun bond polypropylene 20-30 gsm |
|
Nose clip |
Galvanized wire coated with polyethylene or plastic |
|
Ear loops/Ties |
Spandex – Not made from natural rubber latex
Ear loops/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/ Modified color except 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 |
- Test report
|
Product |
Testing Standard | Test code | Test type |
Lab |
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | BFE | Bureau Veritas | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | BFE |
Nelson |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | BFE | SGS | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Cytotoxicity |
Nelson |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Delta P | Nelson | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Differential Pressure |
Bureau Veritas |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Differential Pressure | SGS | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Flammability |
Bureau Veritas |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Flammability | Nelson | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Flammability |
SGS |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Irritation | Nelson | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | PFE |
Bureau Veritas |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | PFE | + 0.1 micron | Nelson |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | PFE | + 0.3 micron |
Nelson |
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | PFE | SGS | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Sensitization |
Nelson |
|
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Splash resistance | Bureau Veritas | |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Synthetic Blood Resistance | 80 mmHg |
Nelson |
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Synthetic Blood Resistance | 120 mmHg | Nelson |
| Fobivi Face Mask (3 Layers) | ASTM F2100 | Synthetic Blood Resistance | 160 mmHg |
Nelson |
|
Fobivi Face Mask (3 Layers) |
ASTM F2100 | Synthetic Blood Resistance | 160 mmHg | SGS |
| Fobivi Face Mask (3 Layers) | EN 14683 | BFE |
Bureau Veritas |
|
|
Fobivi Face Mask (3 Layers) |
EN 14683 | BFE | Nelson | |
| Fobivi Face Mask (3 Layers) | EN 14683 | BFE |
SGS |
|
|
Fobivi Face Mask (3 Layers) |
EN 14683 | Breathability | SGS | |
| Fobivi Face Mask (3 Layers) | EN 14683 | Cytotoxicity |
Nelson |
|
|
Fobivi Face Mask (3 Layers) |
EN 14683 | Delta P | Nelson | |
| Fobivi Face Mask (3 Layers) | EN 14683 | Differential Pressure |
Bureau Veritas |
|
|
Fobivi Face Mask (3 Layers) |
EN 14683 | Irritation | Nelson | |
| Fobivi Face Mask (3 Layers) | EN 14683 | Sensitization |
Nelson |
|
|
Fobivi Face Mask (3 Layers) |
EN 14683 | Synthetic Blood Resistance | Type IIR | SGS |
| Fobivi Face Mask (3 Layers) | EN 14683 | Synthetic Blood Resistance | Type IIR |
Bureau Veritas |
|
Fobivi Face Mask (3 Layers) |
EN 14683 | Synthetic Blood Resistance | 80 mmHg | Nelson |
| Fobivi Face Mask (3 Layers) | EN 14683 | Synthetic Blood Resistance | 120 mmHg |
Nelson |
|
Fobivi Face Mask (3 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 |
From 96% to 99% |
| Bacterial Filtration Efficiency ASTM F2101 |
From 96% to 99% |
|
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 Surgical 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 Surgical Face Mask, 3 layers, Non-sterile.
Dimension: Length: 19.5 cm ±1, Width: 9.5 cm ±1 cm |
| FBV96-01-NS-17.5 |
Fobivi Surgical Face Mask, 3 layers, Non-sterile. Dimension: Length: 17.5 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-NS-15 |
Fobivi Surgical Face Mask, 3 layers, Non-sterile.
Dimension: Length: 15 cm ±1, Width: 9.5 cm ±1 cm |
| FBV96-01-NS-14 |
Fobivi Surgical Face Mask, 3 layers, Non-sterile. Dimension: Length: 14 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-19.5 |
Fobivi Surgical Face Mask, 3 layers, Sterile.
Dimension: Length: 19.5 cm ±1, Width: 9.5 cm ±1 cm |
| FBV96-01-S-17.5 |
Fobivi Surgical Face Mask, 3 layers, Sterile. Dimension: Length: 17.5 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-15 |
Fobivi Surgical Face Mask, 3 layers, Sterile. Dimension: Length: 15 cm ±1, Width: 9.5 cm ±1 cm |
|
FBV96-01-S-14 |
Fobivi Surgical Face Mask, 3 layers, Sterile. Dimension: Length: 14 cm ±1, Width: 9.5 cm ±1 cm |
Reviews
There are no reviews yet.