DETAILED INFORMATION AND INSTRUCTIONS FOR USE
TECHNICAL SPECIFICATION FOR FOBIVI REGULAR FACE MASK 3 LAYER
A. Device Description:
This devices are 3-ply, flat-pleated Regular masks.
The devices are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. There Regular masks to be secured on users via earloops made of spandex and nylon. The devices are sold non-sterile/ sterile and are intended to be single use and disposable. Contact with skin:
Type: Surface Device – Incontact Skin
Contact Duration: Limited – Less than 24 hours
Product description
| Product Name | Fobivi Regular Face Mask |
| Product Model | FBV96 |
| Outer facing layer | Spun bond polypropylene 20-30 gsm |
| Middle layer | Melt blown polypropylene filter 20-30 gsm |
| Inner facing layer | Spun bond polypropylene 20-30 gsm |
| Nose piece | Galvanized wire coated with polyethylene or plastic |
| Ear loops/Ties | Spandex and Nylon – Not made from natural rubber latex Ear loops/head loops/ |
| Mask Style | Flat Pleated |
| Specification and 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 colors except Black |
| Sterility | Non-sterile or Sterile |
| 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 |
| Final packaging | 50 cases in a carton box |
B. Indications 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-steriale.
C. Technological 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 | >98% |
| Bacterial Filtration Efficiency ASTM F2101 | >98% |
| 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 |
D. Storage and Transportation
This Regular face mask has a shelf life of three(3) years. 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). Devide should be stored in clean, dry conditions within the temperature range: – 20°c to + 30°C with a maximum relative humidity <80%. When storing or transporting this device use original packaging provided.
Standards
ISO 13485:2016
Reviews
There are no reviews yet.