MADE - Injection Moldable Face Shield

This design has undergone review in a clinical setting and has been found appropriate when fabricated with the printer type and materials specified.

Submitted by:

govoss

Thu, 2020-04-16 10:07

Vertical Tabs

General Information

Model ID

3DPX-013887

Category

Labware & Devices

Device Use

Safety and Personal Protective Equipment

Keyword(s)

Face Shield - Castable/Moldable

The following refers to: 3DPX-013887

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.

Deriviation of DtM face shield that is moldable in a straght pull mold.

Forehead Visor Material: Bayblend FR110 PC/ABS blend.

Elastic Strap Material: Polyester

PLEASE SEE DOCUMENTATION TAB FOR INSTRUCTIONS FOR USE AND OTHER DOCUMENTATION

3D Modeling/CAD Software

Solidworks

Model Origin

Custom illustration/CAD

Documentation

Supplemental Documentation