Custom Silicone Laryngeal Mask

Hygiene is a critical consideration in the production of medical products. For medical face masks, Liquid Silicone Rubber (LSR) molding is commonly used due to its ability to be processed automatically, minimizing contact with the external environment. This automated production process helps reduce the risk of contamination during manufacturing. Silicone itself is easy to sterilize and biocompatible, making it safe for direct contact with human skin. These qualities make silicone an ideal material for medical face masks, ensuring both safety and hygiene throughout the production and use phases.

Basic Information

– Made of Medical silicone, have good biocompatibility, non-toxic

– Reinforced tube special designed for ENT, ophthalmic, dental and other hand and neck surgeries.

– Cuff is thick and durable with a smooth matte finish that assures easy insertions with minimal resistance.

– Have different sizes, suitable for neonate infant child and adult

– Certified by CE, ISO13485 and FDA

– Can be steam autoclaved and reused with confidence up to 40 times.

– Specially designed shape coincides with the laryngopharynx well, reducing stimulation to patient body and improving the cuff seal.

Quality Control

As a professional manufacturer of LSR silicone masks, we follow a comprehensive and meticulous quality control process to ensure that every mask meets the highest medical-grade standards. Key steps in our quality control/assurance process include:

1. Raw Material Inspection: Before production begins, all incoming Liquid Silicone Rubber (LSR) materials are inspected for purity, consistency, and compliance with medical-grade certifications to ensure the material is safe for use in medical devices.
2. Mold and Equipment Calibration: All molding equipment and molds are regularly calibrated and inspected to maintain precision during the production process. This ensures consistent mask dimensions and avoids defects such as misalignments or uneven surfaces.
3. In-Process Monitoring: Throughout the injection molding process, we continuously monitor critical parameters such as injection pressure, temperature, and curing time. Real-time data analysis helps identify and correct any potential deviations early, ensuring uniform product quality.
4. Visual Inspection: After demolding, each mask undergoes a thorough visual inspection to check for any surface imperfections, flash, or deformities. This step ensures that only masks with perfect appearance and structure proceed to the next stage.
5. Functional Testing: Masks are tested for critical functional properties such as elasticity, tear resistance, and sealing performance. These tests ensure that the masks are flexible, durable, and able to provide a secure and comfortable fit.
6. Biocompatibility Testing: As medical devices, all LSR silicone masks must meet stringent biocompatibility standards. We conduct tests to ensure the masks are non-toxic, hypoallergenic, and suitable for prolonged skin contact.
7. Sterilization Validation: If masks are intended for sterile applications, we validate the sterilization process (e.g., ethylene oxide or gamma radiation) to ensure it is effective while maintaining the mask’s material integrity.
8. Final Quality Inspection: Before packaging, each batch of masks undergoes a final inspection for overall quality, including adherence to dimensional specifications, surface smoothness, and performance tests. Only masks that pass this rigorous check are approved for distribution.
9. Packaging Integrity Check: Each mask is individually packed in sterile PE bags or custom packaging. We perform an integrity check on the packaging to ensure it is properly sealed and maintains sterility.
10. Traceability and Documentation: We maintain detailed records for every production batch, including raw material certificates, process parameters, and inspection results. This ensures full traceability and compliance with international quality standards.