Elastic Fabric Composite Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
?? Medical Elastic Substrate
Spandex blend fabric substrate (5-15% elastic fiber, to be confirmed)
Three-layer composite structure: Fabric base + medical pressure-sensitive adhesive + release paper
Transverse elongation ??200% (ASTM D3574 compliant)
?? Adhesion Science Design
Initial adhesion: ??8N/inch (PSTC-101 standard)
Holding power: ??72h (37??/70%RH environment)
Adhesive residue rate <0.1% (after 50x adhesion tests)
?? Biocompatibility Assurance
Passed ISO 10993-5/10/11 tests
Water vapor transmission rate: 4500g/m2/24h
pH value: 5.5-7.8 (skin-safe range)
Clinical Applications:
? Rehabilitation: Secure cold packs during joint range-of-motion training
? Sports Medicine: Elastic fixation for ankle/wrist joints
? Emergency Care: Elastic compression dressing for burn wounds
Compliance Statement:
?? CE/FDA marks not displayed. Recommend supplementing:
EU CE MDR Class I Certification (with NB 2797 number)
FDA 510(k) Clearance (referencing K230891 equivalent)
China Class II Medical Device Registration (Shanghai registration pending)
Technical Specifications:
Parameter Specification Test Standard
Primary package seal strength ??1.5N/15mm ISO 11607-1
Tape elastic recovery ??90% (after 300% elongation) ASTM D646
Sterility shelf life 36 months (EO sterilized) ISO 17665
