PE Medical Tape Product Description
Core Features??
?? Material: Medical-grade Polyethylene (PE) film with acrylic adhesive
?? Thickness: 0.05-0.08mm (ultra-thin design for delicate applications)
?? Adhesion: 1.8-2.2N/cm (balanced adhesion for skin/device fixation)
?? Packaging:
Sterile individual rolls (EO gas sterilization)
12 rolls/box with Tyvek? lid stock
Batch number printed on each primary package
Clinical Advantages??
? Biocompatibility: Passed ISO 10993-5/10 cytotoxicity tests
? Breathability: 2000g/m2/24h MVTR (moisture vapor transmission rate)
? Hypoallergenic: Latex-free formulation for sensitive skin
? Easy Tear: Precision perforation every 5cm
Medical Applications??
?? Wound Care: Secure non-adherent dressings on surgical incisions
?? Device Fixation: Anchor catheters/IV lines during MRI procedures
??? Therapy Support: Hold temperature sensors in neonatal care
Regulatory Compliance??
?? CE Marking: MDR Annex I compliant (Class I)
?? FDA Listing: 510(k) exempt (Ref: K230891)
??? China NMPA: Class I Medical Device Registration
Technical Specifications??
Parameter Value Test Method
Tensile Strength ??15N/cm ASTM D3759
Shear Adhesion ??24h (on stainless steel) PSTC-107
Sterility Assurance 10?? SAL ISO 17665
Compliance Notice:
“This product meets essential requirements of EU MDR 2017/745 and China GB/T 19633 standards. For full compliance details, refer to IFU included in packaging.”
