Frequently Asked QuestionsAugust 20, 2020 2023-03-15 20:26
Frequently Asked Questions
Yes, The Communicator™ is a Class II, Code FXX Medical Device as FM86000 ASTM F2100 Procedural / Surgical Mask available in Level 1 and Level 3 barriers of protection.
The Communicator™ mask is a procedural / surgical mask available in 2 levels of protection:
- Level 1 provides low barrier protection for general use in low-risk, non-surgical procedures and exams that do not involve aerosols, sprays and fluids
- Level 3 provides maximum barrier protection without compromising comfort and breathability for use in procedures involving high risk of spray and/or fluids
When used as directed, surgical face masks are effective in reducing the spread of COVID-19. The Communicator™ surgical face mask is FDA approved to be safe to use, according to directions.
Yes, The Communicator™ mask is what we call ADA-effective allowing for the ability to read lips for deaf and heard of hearing persons.
The Communicator™ meets the “Effective Communication” clause of the Americans with Disabilities Act of 1990. The Communicator™ mask has a clear window around the mouth and nose area which allows for lipreading and face reading; this clear window assists those people who are visual communicators.
The Communicator™ surgical face mask is FDA approved to be safe to use, according to directions. There is nothing sprayed on the mask. The Anti-Fog claim is the film, not the mask. There are no chemicals used in the production of the masks. Contains no natural rubber latex.
The Communicator Level 1 is approximately 4.75 inches long and 1.35 inches in the middle and tapers to .5 inch at the end.
The Communicator Level 3 has a 40% larger window and is approximately 4.75 inches long and 2 inches in the middle and tapers to .5 inch at the end.
No, the mask does not fog. The Anti-Fog claim is the film, not the mask. There are no chemicals used in the production of the masks.
Yes, The Communicator™ is an FDA approved Surgical Face Mask with Clear Window.
Regulation: 21 CFR 878.4040
Yes, The Communicator™ mask is Health Canada approved. MDEL 17617
The clear plastic window should be worn on the outside away from the face to ensure proper closure to the sides of the face. Below is a short video example:
Yes, we are happy to provide sample masks for trial before purchasing. Please email email@example.com for sample requests.
No, The Communicator™ mask is available only with ear-loop.
No, custom prints and sizes are not available.
No, there are no expiration dates on The Communicator™ masks. Customers are encouraged to keep masks in climate-controlled environments.
No, The Communicator™ mask is not an N-95 mask. The Communicator™ mask is a surgical-grade medical mask: FDA-approved, Health Canada Approved, and has the CE mark for Europe.
The Communicator™ Level 3 offers maximum protection without compromising comfort and breathability. For use in procedures involving high risk of spray and/or fluids.
The Communicator™ mask is FDA approved as a one-time use disposable surgical face mask. Any cleaning or sanitizing of disposable PPE needs to be cleared by your healthcare facility infectious disease and prevention unit and users assume full responsibility and any risks/liability. Again, this mask is designed to be a one-time use and then dispose of properly.
The Communicator™ is designed to be a single-use disposable surgical face mask; to use the mask in any other way than intended use is not recommended and users do so at their own risk.
Safe’N’Clear sells direct business to business. We do currently have some official distributors in the US.
15155 Technology Drive
Eden Prairie, MN 55344
Oaktree Products, Inc
610 Spirit Valley East
Chesterfield, MO 63005
During COVID-19 pandemic, we are not adding new distributors. If you remain interested in being a distributor after the current health crisis, you may contact us at firstname.lastname@example.org for more information.