The following refers to: 3DPX-013456

The FDA has authorized production of protective face shields outside of the normal clearance pathway during the COVID-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff." This face shield has undergone review in a clinical setting and is recommended when fabricated as instructed.

Product Overview

This face shield design is composed of a laser cut PET-G clear shield and laser cut Polypropylene (Copoly) head band. The design is optimized for rapid fabrication and durability. 12 full units per hour can be produced on a 60 watt CO2 laser platform. It is intended to be cleaned and reused as all parts are non-porous. The head band includes a nose piece to support the face shield, reducing the requirement for a tight fit. This means it is more comfortable over long peroids of usage. It does include an elastic or rubber band  rear closure to insure the face shield does not fall off, but it does not have to be as tight as designs without a nose piece. The nose pices can be removed if not desired. The Polypropylene (Copoly) frame is flexible, durable and forms well when bent. This allows for a very customizable and comfortable fit for the user.

Although this design is intended for fabrication by laser cutting, the planar nature of the parts and can be easily produced by 3D printing or injection molding.

Product Point of View

Healthcare workers responding to COVID-19 who face PPE (personal protection equipment) supply gaps while waiting for domestic face shield production to catch up with demand NEED a transparent face shield that:

• limits aerosol and splatter exposure from in front and above, while providing top ventilation
• reduces aerosol and splatter exposure on N95 and other face masks
• is re-usable for a single user (can survive multiple daily washes; transparent visor can be replaced from readily sourced materials when worn out)
• is easy to fabricate within a few days of design approval (ie no complex supply chains or production bottlenecks)
• is comfortable to wear and easy to don and doff (as it will be taken on and off dozens of times in a twelve-hour shift)
• provides protection to broader area of face compared to standard safety goggles or glasses

Bill of Materials

• Sheet Polypropylene (Copoly) 3/16” thickness
• Film PET-G up to .016” thickness
• Elastic band, cord, or 3.5” rubber bands (2 per unit)

Instructions for Use and Assembly

1. Laser Cut 3 frame parts (frame, nose, and H-clip) from Polypropylene (CoPoly) and face shield from PET-G or similiar plastic.
2. Attach face shield to headband on the four mounting pegs.
3. Attach elastic to headband C-rings, adjust to fit.  Some users may find 1 3.5” rubber band is too tight, consider chaining elastic bands as necessary or using multiple rubber bands.
4. To clean, follow CDC recommendations in Strategies for Optimizing the Supply of Eye Protection - Selected Options for Reprocessing Eye Protection. DO NOT submerge or soak 3D-printed headband in cleaning solution as the headband may absorb the solution and leak it out onto the wearer’s forehead over time.
5. Discard and replace the transparent visor as appropriate, after excessive wear or fogging.  

FDA Notice on Emergency Response

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-health-care-entities-fda-department-veterans-affairs-national