Skin-Tone Non-Woven Fabric Tape Product Description
(Medical Device Grade Professional Version)
Core Advantages:
?? Bionic Skin Color Design
Medical-grade non-woven fabric substrate (40-60g/m2, to be confirmed)
Three-layer structure: Non-woven fabric + medical acrylate adhesive + silicone release paper
Color matched to Asian skin tones (#F5E6D3, tolerance ??5%)
?? Hypoallergenic Formulation
Passed skin irritation test (ISO 10993-10)
Latex-free acrylate adhesive
Water vapor transmission rate ??2500g/m2/24h
?? Clinical Compatibility
Initial adhesion: 1.5-2.0N/cm (PSTC-1 standard)
Holding power: ??48h (37?? environment)
Easy-tear design: Serrated edge (no scissors required)
Clinical Applications:
? Pediatrics: Umbilical cord care for newborns
? Dermatology: Post-phototherapy wound protection
? Aesthetic Medicine: Post-minimally-invasive surgery coverage
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 ??30N/cm ASTM D5035
Sterilization residue EO??0.5??g/g ISO 10993-7