Non-Woven Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
?? Medical-Grade Non-Woven Substrate
Non-woven fabric: 30-60g/m2 (to be confirmed)
Composite structure: Polyester/viscose blend (??70% synthetic fibers)
Fiber diameter: 1.0-3.0??m (thermal bonding process)
?? Breathable Hypoallergenic Design
Passed cytotoxicity test (ISO 10993-5)
Silicone adhesive system (latex-free)
Air permeability: ??4500g/m2/24h (ASTM D737)
?? Clinical Performance
Initial tack: 2.0-2.5N/cm (PSTC-1 method)
Shear adhesion: ??72h (40??/75%RH)
Clean removal: ??0.2N/cm residue
Clinical Applications:
? Operating Room: Secure endotracheal tubes/surgical drapes
? Wound Care: Post-operative dressing fixation
? Emergency: Splint stabilization in trauma cases
Compliance Statement:
?? Regulatory marks not visible. Required certifications:
EU MDR Class I (Annex I compliance)
FDA 21 CFR Part 878.4425 (general controls)
China YY/T 0148-2006 standard
Technical Specifications:
Parameter Specification Test Method
Tensile strength ??30N/cm (MD/CD) EN 13934-1
Water vapor transmission ??4500g/m2/24h ASTM E96
Sterility assurance SAL 10?? ISO 17665
Packaging Configuration:
Sterile roll: 10m??5cm (core diameter 38mm)
Double-layer packaging: Tyvek? lid + PET/PE pouch
Batch coding: Laser-etched expiration date
