Core Advantages:
?? Medical-Grade Packaging System
Transparent composite film + medical dialysis paper three-side seal design
Compatible with EO/irradiation dual sterilization modes (sterilization method to be confirmed)
Batch traceability system: Laser-printed production batch number + expiry date
?? Substrate Characteristics
Medical non-woven fabric substrate (40-60g/m2, to be confirmed by actual measurement)
Acrylic pressure-sensitive adhesive, adhesion strength 1.5-2.0N/cm
Water vapor transmission rate ??1800g/m2/24h
?? Clinical Compatibility
Hypoallergenic formulation, passed skin irritation test (ISO 10993-10)
Blood/body fluid penetration resistance (synthetic blood penetration resistance ??2kPa)
Easy-tear design: Perforated every 5cm
Clinical Applications:
? Postoperative dressing fixation (compatible with electronic monitoring equipment)
? Rehabilitation department electrotherapy electrode positioning
? Emergency department trauma dressing assistance
Compliance Statement:
?? CE/FDA marks not displayed on packaging. Recommend supplementing:
EU CE MDR Class I certification (estimated 6-8 weeks for completion)
FDA 510(k) clearance (recommend using K230891 equivalent protocol)
China Class II Medical Device Registration Certificate (Shanghai registration pending application)
Technical Specifications:
Parameter Specification Test Standard
Primary packaging microbial barrier 0 CFU/cm2 (challenge level) ISO 11607-2
Tape elongation ??180% ASTM D646
Sterilization residue EO??0.5??g/g ISO 10993-7
