?? Medical-Grade Materials
Made of medical-grade polypropylene (PP) or high-transparency PE film
Latex-free formulation, certified by skin irritation tests
Individual sterile packaging with Tyvek? (DuPont) material, EO sterilized
?? Sterile Packaging System
Primary packaging complies with GB/T 19633.1 standards
Produced in ISO Class 7 cleanroom (300,000-grade)
Ventilated window design balances sterile barrier and gas exchange
?? Global Regulatory Compliance
EU CE Certification (MDR 2017/745) with NB 2797
FDA 510(k) Clearance (K230891)
China Class II Medical Device Registration (Shanghai No. 20252141289)
Clinical Applications:
? Operating Rooms: Secure catheters/sutures, compatible with laparoscopic instruments
? Rehabilitation Departments: Elastic bandage fixation for ultrasound therapy
? Emergency Rooms: Rapid trauma dressing, compatible with negative pressure drainage
Technical Specifications:
Base material thickness: 0.08mm (medical PP)
Adhesion strength: ??2.5N/cm (ASTM D3330)
Water vapor transmission rate: 3000g/m2/24h
