Instruction for Use
- Cover your mouth and nose with the mask and make sure there are no gaps between your face and the mask.
- Avoid touching the mask while using it, if you do, clean your hands with sanitizer or soap and water.
- Make sure the orange (colored) side of the face mask is facing outwards. Color variation of the mask may occur, including darkening of the original shade of color.
How To Wear Folia’s Mask Correctly
- Clean your hands with soap and water, or hand sanitiser, before touching the mask.
- Hold the mask with the stiff bendable strip on top, and the colored side facing outwards.
- Hold the mask by the ear loops and place a loop around each ear, mould or pinch the nose strip to conform to the shape of your nose.
- Pull the bottom of the surgical mask over your mouth and chin.
How To Remove Folia’s Mask Correctly
After use, the mask will be dirty / contaminated and must be removed and disposed of properly. Follow these instructions while removing your mask:
- Clean your hands with soap and water, or hand sanitiser, before touching the mask.
- Avoid touching the front of the mask if possible. Only touch the ear loops.
- Hold and unhook both ear loops and gently lift the mask away from your face.
- Holding the mask only by the ear loops, dispose of the mask in the trash.
- Clean your hands with soap and water or hand sanitizer again before touching anything else.
Materials of Construction
Nonwoven paper, polypropylene, silver (outer layer), melt blown polypropylene (middle layer), nonwoven polypropylene(inner layer), elastic ear loop string, metal/plastic nose band.
Warnings
- This mask is not intended to be used in the presence of a high intensity heat source or flammable gas. Keep away from heat and flame.
- Single use only, please discard and dispose after one use.
- DO NOT use if the package is damaged
- Discard 3-ply face masks if the mask becomes wet from fluids, droplets, or sweat.
DO NOT wash 3-ply face masks.
Regulatory disclaimer for US market
Folia's face mask is sold as a non-filtering mask under the non-surgical FDA Emergency Use Authorization. Our silver antimicrobial preservative is a low dose that limits microbial growth in order to keep the mask clean. It is not intended to offer antimicrobial or antiviral protection to the wearer, nor is it intended to reduce or prevent infection.
Masks made with Folia’s silverized nonwoven outer coverstock including Folia Silver Mask:
- Are not intended for use as a surgical mask or to provide liquid barrier protection
- Are not to be used in a clinical setting where infection risk through inhalation exposure is high
- Are not intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction
- Are not a respiratory protective device, and therefore should not be used for particulate filtration; and
- Are not for use in high risk aerosol generating procedures.
- Have not been FDA cleared or approved
- Have been authorized by FDA under an EUA for use as source control by the general public as well as by Health Care Professionals in healthcare settings as to help prevent the spread of infection or illness during the COVID-19Pandemic.
- Are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C.§ 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.