Medical Silk Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
??? Medical-Grade Silk Substrate
Silk composition: 100% mulberry silk (or ??30% synthetic fiber reinforcement)
Precision weaving structure: Plain/twill weave (warp/weft density ??200T)
Fiber diameter: 15-25??m (degumming process)
?? Ultra-Thin Breathable Design
Passed sensitive skin test (ISO 10993-10)
Medical acrylate adhesive (hypoallergenic formula)
Water vapor transmission rate ??5000g/m2/24h
?? Clinical Compatibility
Initial adhesion: 1.2-1.5N/cm (PSTC-1 standard)
Holding power: ??24h (37?? environment)
Residue-free removal (??0.1N/cm adhesion residue)
Clinical Applications:
? Burn Unit: Neonatal/geriatric sensitive skin fixation
? Plastic Surgery: Minimally invasive incision precise dressing
? Rehabilitation: Precision instrument sensor 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 ??18N/cm ASTM D5035
Sterilization residue EO??0.5??g/g ISO 10993-7
