Adhesive-backed SpO2 Probe Fixation Pads

Our Adhesive-Backed Pulse Oxygen Probe Fixation Patch is a specialized medical accessory designed to securely and comfortably secure pulse oximeter probes to patients' fingers, toes, or earlobes during continuous SpO₂ monitoring. This single-use fixation patch ensures optimal probe positioning for accurate signal acquisition while preventing motion artifacts and probe displacement in clinical, emergency, and home care settings. The patch serves as a critical interface between sensor and patient, maintaining consistent optical alignment for reliable oxygen saturation readings throughout the monitoring period.

The fixation patch features a precision-engineered multi-layer construction comprising a medical-grade non-woven fabric or breathable polyurethane foam backing, a hypoallergenic acrylic or silicone-based adhesive layer, and a perforated release liner for easy application. The production process utilizes advanced rotary die-cutting and high-pressure lamination technologies to ensure consistent dimensions (±0.5mm tolerance) and uniform adhesive coating weight (typically 30-50 g/m²). The backing material is selected for optimal breathability (MVTR > 500 g/m²/24hr) to prevent skin maceration during extended wear periods of 24-72 hours. The medical-grade adhesive formulation provides secure fixation (peel strength 1.2-2.0 N/cm) while enabling painless, residue-free removal, critical for neonatal, pediatric, and geriatric populations with sensitive skin. Each patch is designed with ergonomic finger-shaped contours and positioning guides to accommodate various probe types and finger sizes. Manufacturing occurs in ISO Class 7 (Class 10,000) cleanrooms with strict environmental controls for temperature (18-26°C) and humidity (40-60% RH) during adhesive coating, lamination, and packaging operations. All raw materials undergo rigorous incoming inspection according to USP and EP pharmacopeial standards, with batch-specific certificate of analysis documentation maintained in the Device History Record (DHR) as required by 21 CFR Part 820 .

As a specialized OEM/ODM manufacturer with vertically integrated operations, we maintain strict quality control across the entire supply chain from raw material sourcing to finished product sterilization. Our facility operates under ISO 13485:2016 certified quality management systems with annual surveillance audits ensuring continuous compliance with global regulatory requirements . We have invested in fully automated production lines featuring precision adhesive coating, vision inspection systems, and sterile barrier packaging capabilities, achieving production capacities exceeding 100 million units annually. Our technical team specializes in custom formulations for specific applications including neonatal intensive care, long-term monitoring, and challenging patient populations requiring extended wear times or enhanced adhesion under moist conditions. With over 15 years of contract manufacturing experience, we serve major medical device brands requiring private labeling, custom packaging configurations, and regulatory support for global market access. Our quality management system incorporates Corrective and Preventive Action (CAPA) processes and post-market surveillance procedures aligned with FDA expectations for continuous improvement .

Our Adhesive-Backed Pulse Oxygen Probe Fixation Patches are manufactured in full compliance with international regulatory standards:

• ISO 13485:2016: Full certification for medical device quality management systems with scope covering design, development, and manufacture of medical adhesive products and fixation devices
• FDA Establishment Registration: Facility registered with U.S. Food and Drug Administration; products listed under appropriate device classification (Product Code relevant to accessories)
• CE Marking (MDR): Certified under European Medical Device Regulation (EU) 2017/745 for Class I medical devices, with technical documentation reviewed for general safety and performance requirements
• ISO 10993 Biocompatibility: Comprehensive testing passed for cytotoxicity (ISO 10993-5), skin sensitization (ISO 10993-10), and irritation (ISO 10993-23), with full biological evaluation report available
• REACH & RoHS Compliant: Manufacturing processes free from hazardous substances including phthalates, latex, and heavy metals; material declarations available upon request
• NMPA Certification: Valid Medical Device Production License for China market access where required
• Sterilization Validation: EO sterilization or gamma irradiation validated per ISO 11135 or ISO 11137 standards, with sterility assurance level (SAL) of 10⁻⁶
• Shelf Life Stability: Validated 24-36 month shelf life under controlled storage conditions (10-30°C, 20-80% relative humidity) with accelerated aging studies per ASTM F1980

Our Adhesive-Backed Pulse Oxygen Probe Fixation Patches represent the convergence of precision engineering and patient-centered design, delivering the secure fixation and signal integrity required for accurate pulse oximetry in diverse clinical applications.