Headgear with Replacement Face Shield

Headgear with Replacement Face Shield

$20.00

What’s included?

  • 1 3D Printed Headband
  • 1 Clear Plastic Shield
  • 1 Elastic Head Strap

Please Note: The clear plastic shield will ship unattached.

Limit 15 per order.

Category:

Description

The face shields that are available from R-Dent include a 3D printed headband, clear plastic shield, and an elastic head strap. The plastic shield can be reused after being thoroughly sanitized.

3D Printed Headband

The 3D printed headband uses a tan material (DPR 10) in a solid, open gap design. The clear plastic shield can be snapped onto the headband via an easy-to-use, interlocking component.

Clear Plastic Shield

The clear plastic shield is made of a thin, polyester sheet. It is attached to the 3D printed headband. The exact product offering may differ due to the availability of the plastic sheets.

The shield can be reused after thorough cleaning in between patients. While this recommendation is made based on the feedback from physicians and infection control groups, every hospital bears the responsibility to determine the appropriate use/reuse protocols for all PPE based on a review of the product by their own infection control group.

Face Shield Disinfection

Face shields are not considered sterile out of their packaging and should be disinfected prior to first use. Please consult the CDC for their latest guidance on disinfectants known to be effective against the spread of COVID-19. The following cleaning materials may be deemed appropriate: 

  • Soap and water
  • Isopropanol (70%) wipe

The following are not compatible with DPR 10 and should not be used to disinfect face shields:

  • Hydrogen peroxide vapor sterilization
  • Autoclave
  • Soaking in isopopanol or other organic solvents

FDA Information

Regulatory Status

In the Unite States, face shields are considered a Class 1 510(k) exempt product by the Federal Drug Administration. Based on current FDA guidelines, these face shields do not require FDA clearance. 

FDA Guidance

This product is not a surgical mask or full face respirator. These face shields are not recommended for any of the following settings:

 
  • Surgical settings
  • Where significant exposure to liquid, bodily, or other hazardous fluid may be expected
  • Clinical settings where infection risk levels through inhalation exposure are high (without the use of a primary barrier such as an N95 or surgical mask
  • Use in the presence of a high intensity heat source or flammable gas

The product does not make any claims of particular filtration or possession of antibacterial or anti-viral properties.

 
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