Medical Cotton Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
?? Medical-Grade Pure Cotton Substrate
Cotton fabric: 60-80g/m2 (to be confirmed)
Single-layer composite structure: Pure cotton gauze + medical pressure-sensitive adhesive + silicone release paper
Fiber diameter: 20-40??m (combed cotton process)
?? High Breathability & Hypoallergenic Design
Passed skin irritation test (ISO 10993-10)
Natural rubber adhesive (with minor synthetic fiber reinforcement)
Water vapor transmission rate ??4000g/m2/24h
?? Clinical Compatibility
Initial adhesion: 2.2-2.5N/cm (PSTC-1 standard)
Holding power: ??72h (37?? environment)
Easy-tear design: Pre-cut serrated edge
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 8-10 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 ??35N/cm ASTM D5035
Sterilization residue EO??0.5??g/g ISO 10993-7
