Custom Medical Silicone Rubber Respirator Masks

Fecision manufactures custom medical silicone rubber 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 with ISO Class 8 cleanroom and Class 100,000 cleanroom production
Get A Free Quote
Medical silicone rubber respirator mask

Custom Respirator Mask Manufacturing Service

Medical breathing masks need to seal comfortably against the face and maintain that fit during use. Fecision develops custom silicone rubber mask components from the initial drawing through production, with material selection and inspection planned around the intended patient contact.

We use LSR injection molding to produce mask components for respiratory equipment, including CPAP and anesthesia systems. Our work covers the mask body and its soft sealing interfaces, with ISO Class 8 cleanroom production and documentation available to meet project requirements.

Medical silicone rubber breathing mask parts

Liquid Silicone Rubber 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 is selected for the intended duration and type of skin contact. Available ISO 10993 material reports can support that assessment; suitability must be confirmed for the finished component.

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 Rubber Respirator Masks

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

Full-face silicone rubber respirator mask
Full-face

Full-Face Silicone Rubber 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 rubber nasal respirator mask
Nasal

Silicone Rubber 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 rubber nasal pillow mask component
Nasal pillow

Silicone Rubber 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 rubber 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.

ISO Class 8 cleanroom 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 produced by LSR overmolding. 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 rubber sealing edge
  • Precision shut-off control to prevent silicone rubber 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 rubber 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 rubber 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 8 cleanroom production for medical silicone rubber respirator mask parts

ISO Class 8 cleanroom production for medical silicone rubber parts

Medical silicone rubber mask components often need cleaner handling than standard industrial silicone rubber parts. Fecision supports ISO Class 8 cleanroom production, also described as Class 100,000 cleanroom production, for respiratory silicone rubber components where particle control, surface cleanliness, packaging, and lot traceability matter.

ISO Class 8 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 rubber 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
  • ISO Class 8 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 Rubber Respirator Masks?

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

Get A Free Quote