▎Products Description
Medical-grade PVC (ISO 10993, USP Class VI, DEHP-free). Biocompatible. Request samples!
Medical-grade PVC (ISO 10993, USP Class VI, DEHP-free). Biocompatible. Request samples!
▎Products Description
30+ Years PVC Modification Technology · ISO Certified Manufacturer
Export to 120+ Countries Worldwide · SGS, Intertek, Bureau Veritas Verified
SmallBoss Medical Grade PVC Compound is a non-toxic, non-DEHP formulation engineered for medical device manufacturing. Designed to meet stringent biocompatibility standards, our compound delivers exceptional clarity, flexibility, and safety for infusion tubing, blood bags, catheters, oxygen masks, and other critical medical applications.
Compliant with ISO 10993-5 Cytotoxicity and USP Class VI standards, our compound supports ETO, Gamma, and autoclave sterilization. With 30+ years of PVC modification expertise, we provide both extrusion and injection molding grades with customizable hardness from Shore A 60 to 95, meeting diverse medical device requirements worldwide.
| Parameter | Value |
|---|---|
| Appearance | Clear transparent granules |
| Specific Gravity | 1.19 ± 0.03 g/cm3 |
| Hardness | 75 ± 3 Shore A |
| Tensile Strength (min.) | ≥ 15 MPa |
| Elongation at Break (min.) | ≥ 300 % |
| Haze (max.) | ≤ 5 % |
| Thermal Stability @ 200°C | ≥ 40 min |
| Residual VCM (max.) | < 1 ppm |
| Heavy Metals (max.) | ≤ 10 ppm |
| Biocompatibility | Pass (non-cytotoxic) |
| USP Class VI | Pass |
| Sterilization | ETO, Gamma, Autoclave |
| DEHP / Phthalate | Free (non-phthalate) |
| Regulatory Compliance | REACH, RoHS, CA Prop 65 |
| Processing Method | Extrusion / Injection Molding |
Our compound produces flexible tubing with excellent kink resistance, maintaining consistent fluid flow rates even under bending and compression during clinical use.
High-clarity formulation achieves haze below 5%, enabling clear visual monitoring of fluid flow, air bubbles, and medication delivery during medical procedures.
Our compound maintains color stability and mechanical properties after ETO, Gamma, and autoclave sterilization, ensuring product integrity throughout the sterilization cycle.
Non-DEHP, non-phthalate formulation with low extractables profile meets ISO 10993-5 and USP Class VI biocompatibility standards, minimizing patient exposure risk and accelerating regulatory approval.
Every batch undergoes rigorous QC testing including mechanical properties, dimensional stability, and color consistency. Our ISO-certified lab ensures compound performance matches specifications batch after batch.
Extruded clear tubing for IV infusion sets, transfusion sets, and drip chambers requiring high clarity, flexibility, and consistent flow rate performance.
Flexible PVC sheets for blood bags, plasma bags, and transfer packs requiring excellent transparency, low extractables, and long-term stability.
Medical-grade tubing for urinary catheters, drainage systems, and enteral feeding tubes requiring kink resistance, biocompatibility, and patient comfort.
Injection-molded oxygen masks, nasal cannulas, and resuscitator bags requiring soft touch, transparency, and odor-free performance.
Custom extruded profiles for specialized applications in industrial and commercial settings.
Tailored compounds developed to meet specific customer requirements for hardness, color, and processing characteristics.
IV Infusion & Transfusion Sets
Catheters & Drainage Tubing
Specialty Profiles
Tongxiang Small Boss Special Plastic Products Co., Ltd. has been specializing in PVC compound manufacturing Since 1992 (30+ Years). As a National High-Tech Enterprise and Specialized "Little Giant" company, we combine advanced formulation expertise with massive production capacity to serve medical device manufacturers worldwide.
Our 120+ high-speed extrusion lines deliver 6,000 tons per month, ensuring stable supply for large-scale medical production programs. We collaborate with Zhejiang University, Hohai University, and Xi'an Jiaotong University for continuous R&D innovation in medical-grade PVC formulations.
As an ISO-certified manufacturer, we maintain rigorous quality control systems. Our products are tested and verified by international third-party laboratories including SGS, Intertek, and Bureau Veritas.
PVC Modification Technology
Production Capacity
Global Export Coverage
Custom Formulations
Get Free Samples & Technical Consultation
Email: zt02@smallboss.com | Website: www.ztsmallboss.com
30+ Years PVC Modification Technology · ISO Certified Manufacturer
Export to 120+ Countries Worldwide · SGS, Intertek, Bureau Veritas Verified
SmallBoss Medical Grade PVC Compound is a non-toxic, non-DEHP formulation engineered for medical device manufacturing. Designed to meet stringent biocompatibility standards, our compound delivers exceptional clarity, flexibility, and safety for infusion tubing, blood bags, catheters, oxygen masks, and other critical medical applications.
Compliant with ISO 10993-5 Cytotoxicity and USP Class VI standards, our compound supports ETO, Gamma, and autoclave sterilization. With 30+ years of PVC modification expertise, we provide both extrusion and injection molding grades with customizable hardness from Shore A 60 to 95, meeting diverse medical device requirements worldwide.
| Parameter | Value |
|---|---|
| Appearance | Clear transparent granules |
| Specific Gravity | 1.19 ± 0.03 g/cm3 |
| Hardness | 75 ± 3 Shore A |
| Tensile Strength (min.) | ≥ 15 MPa |
| Elongation at Break (min.) | ≥ 300 % |
| Haze (max.) | ≤ 5 % |
| Thermal Stability @ 200°C | ≥ 40 min |
| Residual VCM (max.) | < 1 ppm |
| Heavy Metals (max.) | ≤ 10 ppm |
| Biocompatibility | Pass (non-cytotoxic) |
| USP Class VI | Pass |
| Sterilization | ETO, Gamma, Autoclave |
| DEHP / Phthalate | Free (non-phthalate) |
| Regulatory Compliance | REACH, RoHS, CA Prop 65 |
| Processing Method | Extrusion / Injection Molding |
Our compound produces flexible tubing with excellent kink resistance, maintaining consistent fluid flow rates even under bending and compression during clinical use.
High-clarity formulation achieves haze below 5%, enabling clear visual monitoring of fluid flow, air bubbles, and medication delivery during medical procedures.
Our compound maintains color stability and mechanical properties after ETO, Gamma, and autoclave sterilization, ensuring product integrity throughout the sterilization cycle.
Non-DEHP, non-phthalate formulation with low extractables profile meets ISO 10993-5 and USP Class VI biocompatibility standards, minimizing patient exposure risk and accelerating regulatory approval.
Every batch undergoes rigorous QC testing including mechanical properties, dimensional stability, and color consistency. Our ISO-certified lab ensures compound performance matches specifications batch after batch.
Extruded clear tubing for IV infusion sets, transfusion sets, and drip chambers requiring high clarity, flexibility, and consistent flow rate performance.
Flexible PVC sheets for blood bags, plasma bags, and transfer packs requiring excellent transparency, low extractables, and long-term stability.
Medical-grade tubing for urinary catheters, drainage systems, and enteral feeding tubes requiring kink resistance, biocompatibility, and patient comfort.
Injection-molded oxygen masks, nasal cannulas, and resuscitator bags requiring soft touch, transparency, and odor-free performance.
Custom extruded profiles for specialized applications in industrial and commercial settings.
Tailored compounds developed to meet specific customer requirements for hardness, color, and processing characteristics.
IV Infusion & Transfusion Sets
Catheters & Drainage Tubing
Specialty Profiles
Tongxiang Small Boss Special Plastic Products Co., Ltd. has been specializing in PVC compound manufacturing Since 1992 (30+ Years). As a National High-Tech Enterprise and Specialized "Little Giant" company, we combine advanced formulation expertise with massive production capacity to serve medical device manufacturers worldwide.
Our 120+ high-speed extrusion lines deliver 6,000 tons per month, ensuring stable supply for large-scale medical production programs. We collaborate with Zhejiang University, Hohai University, and Xi'an Jiaotong University for continuous R&D innovation in medical-grade PVC formulations.
As an ISO-certified manufacturer, we maintain rigorous quality control systems. Our products are tested and verified by international third-party laboratories including SGS, Intertek, and Bureau Veritas.
PVC Modification Technology
Production Capacity
Global Export Coverage
Custom Formulations
Get Free Samples & Technical Consultation
Email: zt02@smallboss.com | Website: www.ztsmallboss.com
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