Cufitec Surgical Mask
The Cufitec Surgical Mask covers the wearer’s nose and mouth as a barrier against transfer of microorganisms, body fluids and particulates. It is a nonsterile, disposable mask for single…
The Cufitec Surgical Mask covers the wearer’s nose and mouth as a barrier against transfer of microorganisms, body fluids and particulates. It is a nonsterile, disposable mask for single use. Ear loops hold it in place, and a malleable nosepiece helps conform it to the face.
The pleated mask has four layers: rayon on the outer and inner surfaces and two polypropylene layers between them. The rayon layers contain a 0.5% cuprous iodide anti-influenza coating. Polyurethane and nylon form the ear loops, and polyethylene forms the nosepiece.
Listed Item
The Cufitec® Surgical Mask is a single-use, disposable device, provided non-sterile, and is intended to cover the nose and mouth of the wearer to protect from the transfer of microorganisms, body fluids, and particulates and has an added anti-influenza agent which inactivates specific pathogens under specified contact conditions. The mask is comprised of four layers of materials: rayon layers with added anti-influenza coating (outer and inner layers) and polypropylene layers (two middle layers). All of the construction materials used in this device are commonly used in the construction of surgical facemasks used in current legally marketed devices. The inner and outer layers are coated with an anti-influenza agent (CuI, 0.5% wt.), which inactivates influenza viruses under tested contact conditions using the same mechanism of action. Masks are held in place on the wearer with ear loops (polyurethane and nylon) and contains a malleable polyethylene nosepiece strip to conform to the wearer’s face.
Coating Evidence
The coating inactivated specified influenza virus strains after five minutes of contact with the mask surface in laboratory testing. These test results do not establish a reduction in clinical infection events.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
Record
| Listed by | Nbc Meshtec, Inc., Japan |
|---|---|
| FDA product code | OUK |
| Device type | Surgical Mask With Antimicrobial/Antiviral Agent |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4040 |
| 510(k) | K182766 |
| Record published | 2021-03-31 |
| Record revised | 2023-09-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A1 | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RespoKare | Innonix Technologies Limited | 5 |
| ProGear/Oxafence | Prestige Ameritech | 3 |
| Medline | Medline Industries, Inc. | 1 |
| Meijer | Meijer, Inc. | 1 |
| Curad | Medline Industries, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182766 | 2019-01-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.