Cotton Mini Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
?? Medical-Grade Cotton Substrate
Cotton fabric: 30-60g/m2 (to be confirmed)
Single-layer composite structure: Pure cotton gauze + medical pressure-sensitive adhesive + silicone release paper
Fiber diameter: 15-30??m (combed cotton process)
?? Hypoallergenic Breathable Design
Passed skin irritation test (ISO 10993-10)
Latex-free acrylate adhesive
Water vapor transmission rate ??3000g/m2/24h
?? Clinical Compatibility
Initial adhesion: 1.6-2.0N/cm (PSTC-1 standard)
Holding power: ??48h (37?? environment)
Easy-tear design: Pre-cut serrated edge (no scissors required)
Clinical Applications:
? Pediatrics: Neonatal umbilical cord care/IV cannula fixation
? Dermatology: Small-area eczema dressing fixation
? Rehabilitation: Mild finger joint fixation
Compliance Statement:
?? CE/FDA marks not displayed. Recommend supplementing:
EU CE MDR Class I Certification (estimated 4-6 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 ??20N/cm ASTM D5035
Sterilization residue EO??0.5??g/g ISO 10993-7
