Custom Medical Silicone Respirator Masks

Fecision manufactures custom medical silicone respirator masks and breathing mask components with medical-grade LSR, clean production control, and in-house tooling support.

  • Custom mask cushions, nasal masks, full-face masks, and respiratory seals
  • Medical-grade LSR and platinum cured injection molding
  • ISO 13485 certified and Class 10,000 Cleanroom lab and production
Request A Respirator Mask Quote
Medical silicone respirator mask

Custom Respirator Mask Manufacturing Service

Medical breathing masks need a stable seal, soft skin contact, low irritation, and repeatable fit. Fecision supports custom silicone respirator mask projects from drawing review and material selection to tooling, molding, inspection, and production release.

We support LSR injection molding, cleanroom production, and project documentation for respiratory care, anesthesia, oxygen therapy, CPAP, and ventilator mask components. Typical custom parts include mask bodies, cushions, face seals, tubing connectors, soft interfaces, and related respiratory silicone components.

Medical silicone breathing mask parts

Liquid Silicone Ruber For Respirator Masks

Liquid silicone rubber is widely used in respiratory mask parts because it combines soft skin contact with stable sealing performance after repeated compression.

Soft Skin Contact

Soft LSR grades help the mask seal against the face without creating a hard pressure point. Special formulations can be selected when very low hardness is required.

Compression Recovery

Silicone rubber returns well after compression, which helps the cushion keep its sealing shape during daily use, fitting, cleaning, and storage.

Medical Material Support

Medical-grade LSR can support biocompatibility, ISO 10993 material reports, low irritation, and short- or long-term skin-contact requirements.

Sterilization Compatibility

Depending on the selected grade and part design, LSR respirator mask parts can be reviewed for EtO or autoclave sterilization compatibility.

Types of Silicone Respirator Masks

The mask structure is selected around patient comfort, leak control, breathing mode, pressure level, and the device interface.

Full-face silicone respirator mask
Full-face

Full-Face Silicone Masks

Full-face masks cover the nose and mouth. They allow both nasal and mouth breathing and are often used when mouth leakage must be reduced.

Silicone nasal respirator mask
Nasal

Silicone Nasal Masks

Nasal masks cover the nose only. They offer a more open field of view and are widely used for comfortable respiratory support.

Silicone nasal pillow mask component
Nasal pillow

Silicone Nasal Pillow Masks

Nasal pillow masks use a small contact area at the nostrils. They are lightweight and useful when the user dislikes a larger mask body.

Respirator Mask Manufacturing Process

Fecision connects tooling, material preparation, molding, cleanroom handling, and inspection so custom respirator mask projects can move from sample to production with fewer delays.

Medical silicone material
1

Material Review

We review hardness, color, transparency, sterilization needs and available medical-grade LSR documentation before tooling begins.

mold tooling
2

In-House Tooling

Mold engineers review parting lines, venting, flash control, sealing lips, undercuts, and assembly features for manufacturable mask geometry.

Medical LSR injection molding
3

LSR Injection Molding

Two-part LSR is metered, mixed, injected into a heated precision mold, then cured under controlled temperature and pressure.

Inspection
4

Inspection

Medical mask parts can be produced and inspected under cleanroom controls with particle, appearance, dimension, and packaging checks as required.

Transparent respirator mask
Case Study

Zero-Flash LSR Overmolding On A Transparent Respirator Mask

A respiratory device manufacturer needed a transparent PC mask with a soft LSR seal. The seal had to come out of the mold cleanly, without flash, trimming, or scratches on the clear surface.

  • Insert molding of a clear PC mask body with a soft silicone sealing edge
  • Precision shut-off control to prevent silicone flash on optical surfaces
  • Process tuning for thin sealing lips, clean filling, and stable production
Read Respirator Mask Case Study

Custom Manufacturing Capabilities

We can adjust the silicone grade, hardness, transparency, sealing geometry, connector design, packaging, and inspection plan around the final device requirements.

Medical-grade LSRSkin-contact and respiratory care material options with platinum-cured clean curing systems for medical silicone components
30A-70A Shore ASoft to firm grades for mask cushions and structural parts
22 mm interfaceStandard respiratory connector size or custom interface
Custom colorsTransparent, translucent, solid color, or project-specific color
ISO 10993 reportsBiocompatibility material documentation support
ISO 13485 supportMedical manufacturing workflow and quality records
ISO Class 7 cleanroom production for medical silicone respirator mask parts

ISO Class 7 Cleanroom Production For Medical Silicone Parts

Medical silicone mask components often need cleaner handling than standard industrial silicone parts. Fecision supports ISO Class 7 cleanroom production for respiratory silicone components where particle control, surface cleanliness, packaging, and lot traceability matter.

Cleanroom production can be arranged after molding, trimming, inspection, and packaging steps according to the project requirement. This helps reduce contamination risk and keeps the part release process more predictable for medical device programs.

Why Choose Fecision For Custom Respirator Mask Parts?

Respirator mask projects need more than a soft silicone material. The seal geometry, mold design, flash control, clean handling and documentation all affect final product performance.

  • In-house tooling and mold adjustment for sample feedback
  • Our shop and process are iso 13485 certified
  • Cleanroom production options for medical-use parts
  • Inspection support for dimensions, appearance, hardness, sealing surface
Respirator mask parts inspection and packaging

Need Custom Medical Silicone Respirator Masks?

Send your drawing, 3D file or sample. Fecision can review the material, tooling and molding process before quoting.

Get A Free Quote