Spunlace Plain Weave Composite Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
??? Spunlace Non-Woven Substrate
Spunlace non-woven fabric: 30-80g/m2 (to be confirmed)
Plain weave composite structure: Spunlace + medical acrylate adhesive + silicone release paper
Fiber diameter: 0.5-2.0??m (hydroentanglement process)
?? Hypoallergenic Breathable Design
Passed skin irritation test (ISO 10993-10)
Latex-free acrylate adhesive
Water vapor transmission rate ??3500g/m2/24h
?? Clinical Compatibility
Initial adhesion: 1.8-2.2N/cm (PSTC-1 standard)
Holding power: ??72h (37?? environment)
Easy-tear design: Laser perforated positioning line
Clinical Applications:
? Wound Care: Secure sterile gauze/hydrocolloid dressings
? Catheter Fixation: IV cannula/drainage tube stabilization
? Rehabilitation: Low-friction joint fixation straps
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
