General Warnings and Cautions


WARNING:

  • Do not use in a surgical setting.
  • Do not use where significant exposure to liquid, bodily, or other hazardous fluids may be expected.
  • Do not use in a clinical setting where the infection risk level through inhalation exposure is high.
  • Do not use in the presence of a high intensity heat source or flammable gas.
  • Do not sleep with the mask on.
  • Do not drink alcohol or take medications that cause drowsiness while wearing the mask.
  • Do not use Oxygen while wearing the mask.
  • Do not smoke while wearing the mask
  • Choke hazard. Keep away from children and pets.
  • Take periodic mask breaks by removing the mask at least every two hours.
  • If you experience any health issues, discontinue use immediately and see your physician.
  • Do not sterilize.
  • Filter is single use only, do not reuse. Replace after 12 hours of use or if there’s noticeably increased breathing resistance.
  • Do not use for high-risk aerosol generating products (i.e. painting) or other construction activities.
  • After washing and drying, inspect the Naked Mask clear shell for flaking, air bubbles, or other signs of damage. If any issues are seen, discontinue use and contact Sharp Medical Products.

CAUTIONS:

  • Do not puncture the filters.
  • If a filter is damaged or discolored, or the mask is damaged or cracked, do not use and discard.
  • Keep the mask and filters away from open flames.
  • Do not allow the filter to get wet.
  • Do not fold the filters.
  • This product has not been FDA cleared or approved.
  • This product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.
  • This product is 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(L)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1) unless authorization is terminated or revoked sooner.

List of Body Contacting Materials


A. Shell: neos Zylar 960 impact modified styrene acrylic copolymer, Nanocyte SAF-100 anti-fog coating, Nanomyte SR-Primer 51

B. Gasket: Avient Versaflex CL2250 thermoplastic elastomer

C. Strap: 70% polyester / 30% Latex; Vinyl ink

D. Strap Keepers: Acetal

E. Filter: Filti NP097; 3M 9471LE; 175lb cardstock



Intended Use

The nakedMASK™ Reposable Face mask is intended to be worn by the public or healthcare personnel.


Description of the Device

The nakedMASK™ is composed of three different major parts. The reusable shell, the disposable single-use filter, and the reusable rubber gasket. The reusable shell is a clear material that makes it easier to see the wearer’s face.


Assembly

The nakedMASK™ Reposable Face mask is intended to be worn by the public or healthcare personnel.


1. Wash hands thoroughly with warm, soapy water for at least 20 seconds prior to handling the mask and its components.

2. Thread a strap keeper onto the strap, with the rounded edge of the strap keeper on the side of the strap with the logo. Pull the strap until the strap keeper is on the inside edge of the logo. Repeat on the other side.

3. With the logo facing the shell, thread the strap through the bottom slot of the strap holder on the shell. Loop the strap around and thread through the top slot on the shell until the outer edge of the logo is about an inch away from the mask.

4. Thread the strap ends back through the strap keepers. Pull taut.

5. Place a new filter into the mask. Align the filter with the rib in the center of the shell.

WARNING:

6. Check that the filter is fully seated and is not above the edge of the mask. The filter should fit flush in the recess.

7. Flip the strap over the mask.

8. Place the gasket into the clear mask until it is fully seated by ensuring that the gasket edge is pressed all the way against the clear shell.

WARNING:

9. Check that the filter is not damaged, and the gasket is fully seated. Do not use the filter if it is discolored, punctured, or wrinkled.


Wear


1. Place the mask on your face, then pull the strap over your head.

2. Tighten the strap to ensure proper fit.

3. The strap may be worn in either configuration shown below (A & B) to provide the best seal to your face.


Removal, Disassembly & Cleaning


1. Take off the mask by pulling the mask slightly outward and removing.

2. Reverse the assembly instructions to disassemble the mask.

3. Dispose of the filter in the trash or, if used in a healthcare setting, disposed of in accordance with facility policies and procedures.

4. Wash reusable components (not the filter) with warm, soapy water for a minimum of 1 minute (do not sterilize).

5. Rinse reusable components with clean water to remove all soap.

6. Allow all components to air dry completely before assembling.


Troubleshooting


1. If you experience unwanted fogging, spread a thin layer of baby shampoo on the inside of the shell with a cloth. Lightly rinse and air dry before inserting the filter.

2. If the mask is tight or uncomfortable, adjust the strap length or the position of the strap on your head.


Maintenance


1. Always be aware of the state of your mask components. Discard and replace gasket, shell, or filter if damaged, discolored, or punctured.

2. Clean mask if soiled. Discard and replace filter after each use.


Storage


Store the nakedMASK™ and replacement filters away from direct sunlight.