Spunlace Non-Woven Plain Weave Composite Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
?? Spunlace Non-Woven Substrate
Spunlace fabric: 40-70g/m2 (to be confirmed)
Plain weave composite structure: Spunlace non-woven + medical pressure-sensitive adhesive + silicone release paper
Fiber diameter: 0.5-2.0??m (high-pressure water jet process)
?? High Breathability & Hypoallergenic Design
Passed skin irritation test (ISO 10993-10)
Latex-free acrylate adhesive
Water vapor transmission rate ??3800g/m2/24h
?? Clinical Compatibility
Initial adhesion: 1.8-2.2N/cm (PSTC-1 standard)
Holding power: ??48h (37?? environment)
Easy-tear design: Laser-perforated positioning lines
Clinical Applications:
? Operating Room: Secure surgical dressings/drainage tubes
? Trauma Department: Large-area burn wound fixation
? Rehabilitation: Sports injury protection & fixation
Compliance Statement:
?? CE/FDA marks not displayed. Recommend supplementing:
EU CE MDR Class I Certification (estimated 6-8 weeks for completion)
FDA 510(k) Clearance (referencing K230891 equivalent protocol)
China Class I Medical Device Registration (Shanghai???? pending)
Technical Specifications:
Parameter Specification Test Standard
Microbial barrier 0 CFU/cm2 (challenge level) ISO 11607-2
Tape breaking strength ??25N/cm ASTM D5035
Sterilization residue EO??0.5??g/g ISO 10993-7
