MADE - Injection Moldable Face Shield

Model Description

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

Reviewer Notes
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.

*This model sourced with permission from the NIH 3D Print Exchange*

Files

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TDP Category Type Filename Size
General Instructions application/pdf Head Strap PDF.PDF 29.67 KB
General Instructions application/pdf IFU_Face_Shield _Full Rev 1.2.pdf 153.58 KB
General Instructions application/pdf IFU_Face_Shield _Abrev R1_2_0.pdf 131.32 KB
General Instructions application/pdf Head Strap_REV C_0.PDF 24.93 KB
General Instructions application/pdf Clear Plastic Shield Rev C_0.PDF 25.31 KB
STL File Head Visor_0.STL 11.75 MB
Blender-generated-x3d Head Visor_0.STL60c0e4ae6550d.x3d 8.58 MB

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Part Information

Additional Owner's Names

jsaly

AMCPR Type

designPackage

Model Number

3DPX-013887

Review Process

simple

Public

Yes
2021-06-09T15:56:07

Materials

Polymer

General Build Material

ABS

Quality Standards

Submission Path

production

Assembly Required

No
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