Introduction:
Our silicone oxygen masks,are available in custom configurations using medical grade silicone or liquid silicone. For cost-effective solutions, we use compression molding, ideal for standard masks with lower quality requirements. For masks demanding superior precision and durability, we employ liquid silicone injection molding, ensuring exceptional performance. These masks are designed to deliver Positive Airway Pressure (PAP) for Obstructive Sleep Apnea (OSA) treatment, offering a more comfortable and effective alternative to traditional full-face masks. Customization options are available to meet specific needs and preferences.
Details:
Material:100%Silicone
Color:Customized
Hardness: According to your requirement
Working temperature: -40c~230c
OEM :Available
The Advantages of Silicone Oxygen Masks:
1. Ease of use: Silicone standard supraglottic airway insertion is fast and convenient, reducing potential discomfort and complications for patients.2. Versatile: Suitable for routine airway management in a variety of settings, including emergency medicine, anesthesia, and intensive care.
3. Comfort: The unique anatomical shape of the device provides excellent patient comfort and reduces the risk of complications such as sore throat or laryngospasm.
4. Safety: The device is made of medical-grade silicone, which is biocompatible, reduces the risk of allergic reactions, and is safe for both short-term and long-term use.
5. Effective: The device provides an effective airway management solution, ensuring optimal oxygenation and ventilation for a range of patients, including those with difficult airways.
Quality Control Process:
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Factory Show:
Our factory is equipped with a range of specialized workshops to deliver top-notch manufacturing solutions. We operate a Silicone Compression Molding Workshop, a Plastic Injection Molding Workshop, and a Silicone Injection Molding Workshop, each designed to meet the highest standards of precision and efficiency. Our Class 8 Clean Room ensures the production of high-purity components, while our Test Workshop is equipped with advanced testing equipment to uphold rigorous quality control. With the capacity to produce thousands of units per month, our facility is well-equipped to handle diverse production needs, ensuring reliable and high-quality manufacturing for all our clients.
