Face Mask EarSavers

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:

3dpdesignlab

Tue, 2020-04-28 19:34

Vertical Tabs

General Information

Model ID

3DPX-014103

Category

Labware & Devices

Device Use

Clinical Equipment or Adapter

Keyword(s)

face mask ear saver, surgical mask ear relief, ear pain relief, mask elastic, 3D Printed Face Mask Strap Holder

EarSavers are designed to help relieve the chafing on the backs of the ears associated with wearing face masks.

The small size is designed to be used with all hair styles. It is designed to rest against the base of the head and remove the ear bands from the backs of the ears.

The medium size is designed to be used when wearing the hair in a ponytail, bun or other style which pulls the hair off of the back of the neck using a hair band. The medium size rests above the ponytail on top of the hair band. It is designed to remove the ear band from the backs and the tops of the ears.

3D Modeling/CAD Software

Autodesk Fusion 360; Tinkercad

Model Origin

Custom illustration/CAD

How to Make

Printer Technology/Material

Polylactic Acid (PLA)

Printer Make/Model

Prusa i3 MK3S

Print Units

Pre- and Postprocessing Instructions

Make sure your first layer isn't too low or one side of the print that's resting against the head or neck will stick out and be sharp.

Attribution

Attribution Instructions

Documentation

Supplemental Documentation

EarSaver Flyer Both Sizes

Small EarSaver Flyer Instructions

Small EarSaver Instructions to include with device

Medium EarSaver Flyer Instructions

Medium EarSaver Instructions to be included with device

Reviewer Notes

The following refers to: 3dpx-014103

The FDA has authorized production of the ear saver 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 ear saver has undergone review in a clinical setting and is recommended when fabricated as instructed.

RESOLVED:

For documentation purposes, we cannot accept links to external websites for printing instructions, instructions for use, etc. Instructions need to be included as a PDF or as text on the NIH 3D Print Exchange website. -05.01.20