Medical & Healthcare

Medical grade silicone leather — ISO 10993 biocompatible and FDA-compliant for medical device contact. Compatible with standard sterilization methods. Disinfectant-resistant surface withstands repeated hospital-grade cleaning without degradation.

Commercial Info
MOQ
500 meters
Lead Time
7 – 15 days
Warranty
12 months
Key Feature
Biocompatible, sterilizable
Physical Properties
Thickness Range
0.23 – 1.5mm(ISO 2286-2)
Width
1350 – 1500 mm
Density
1.0 – 1.3 g/cm³(ISO 1183)
Weight
200 – 700 g/m²(ISO 2286-2)
Mechanical Properties
Tensile Strength
≥ 15 N/mm(ISO 3376)
Tear Strength
≥ 20 N(ISO 34-1)
Elongation at Break
≥ 300%(ISO 3376)
Flex Resistance
≥ 100,000 cycles(ISO 5402)
Medical Safety
FDA Compliance
21 CFR Part 177.2600(IFDA)
Biocompatibility
Passed(ISO 10993)
Anti-bacterial
Available
Sterilizable
EtO / Gamma
Chemical Resistance
Disinfectant Compatible
Alcohol / Bleach
Blood / Sweat Resistant
Yes
Stain Resistance
Excellent(AATCC 127)
Surface Integrity
No degradation after repeated cleaning
Certification & Compliance
REACH Compliance
Passed(EC 1907/2006)
PAHs Content
Passed(AfPS GS 2019:01)
VOC Emission
Zero(ISO 16000-6)
Formaldehyde Emission
E1 Grade(EN 717-1)
Biocompatibility (Cytotoxicity)
Certified(ISO 10993-5:2009)
Polycyclic aromatic hydrocarbons restriction
Passed(21 CFR Part 177.2600)
Flame retardant
Certified(EN 13773 Class 4)
Aviation interior flammability
Passed(FAR 25.853)
01Is silicone leather suitable for direct patient contact applications?Yes, absolutely. Our medical-grade silicone leather is FDA certified (21 CFR Part 177.2600) and ISO 10993-5 biocompatibility tested. It's hypoallergenic, non-cytotoxic, and safe for prolonged skin contact — making it ideal for examination tables, hospital beds, wheelchairs, and other patient-contact applications.
02Can it withstand hospital-grade disinfectants and cleaning protocols?Yes. Our silicone leather is specifically engineered to resist all common medical disinfectants including alcohol (70-90%), bleach solutions, quaternary ammonium compounds, and hydrogen peroxide. See our cleaning guidelines for recommended products and protocols to maximize material lifespan.
03How does silicone leather help prevent hospital-acquired infections?Silicone leather features a non-porous, seamless surface that doesn't harbor bacteria. Learn about our antibacterial properties — it inhibits 99.9% of common pathogens including E.coli and Staphylococcus aureus, significantly reducing cross-contamination risks.
04What certifications does your medical-grade silicone leather have?Our medical-grade silicone leather holds multiple international certifications: FDA 21 CFR Part 177.2600, ISO 10993-5, ISO 10993, REACH and PAHs. Download complete documentation for regulatory compliance.
05How long does medical-grade silicone leather last in healthcare settings?With proper care, our medical-grade silicone leather lasts 10+ years. Our High Performance collection features 200,000+ Martindale cycles and non-hydrolysis formula — engineered for high-traffic medical facilities without cracking, peeling, or fading.
06Can I get samples and technical data sheets for evaluation? Yes, we provide free samples and comprehensive technical documentation including FDA certificates, ISO 10993-5 reports, and cleaning guidelines. Contact us to request evaluation samples for your specific medical application needs.