Covid 19 filter mask

Model Description

Model ID 3DPX-013319Category Labware & DevicesDevice Use Safety and Personal Protective EquipmentKeyword(s) 3D Printed Respirator"This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment, as described in FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Section V B. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects."3D printed emergency respirator designed for use with n95 equivalent filter material. Elastic bands used to secure filter media and hold to wearers head behind ears using a coupling device to reduce ear strain (ie paperclip, 3D printed strain relief strap ((HP design)))3D Modeling/CAD Software TinkerCADModel Origin Custom illustration/CADHospital or Insitutional Affiliation Decatur Memorial HospitalPrinter Technology/Material Material Extrusion Polylactic Acid (PLA)Printer Make/Model Prusa Mk3 Makerbot Replicator+Print Units inchesScale At Given Print Units 100% for large adult, 90% for small adult/childPrinter-specific Build Instructions Specific material PLA or PETGNumber of prints per build 1Build time 1hr 20minPre- and Postprocessing Instructions Light sanding and smoothing can produce a finish that can be molded in silicone and cast in plastic resin.Reviewer Notes 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. - 04.30.20This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment, as described in FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Section V B. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects.*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 images.pdf 223.58 KB
STL File mask flange v4 large_0.stl 511.02 KB
Blender-generated-x3d mask flange v4 large_0.stl60c0bc7cb123a.x3d 333.74 KB

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Part Information

Additional Owner's Names

jsaly

AMCPR Type

designPackage

Model Number

3DPX-013319

Review Process

simple

Public

Yes
2021-06-09T13:04:40

Materials

Polymer

General Build Material

PLA

AM Process

Material Extrusion

Quality Standards

Submission Path

production

Assembly Required

No
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