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Medical Grade PVC Compound


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!


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Products Description

★ Premium Medical Grade Compound Supplier ★

 

30+ Years PVC Modification Technology · ISO Certified Manufacturer

Export to 120+ Countries Worldwide · SGS, Intertek, Bureau Veritas Verified

Product Overview

Small Boss

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.

· Specification

Small Boss
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

· Advantage

Small Boss

🔶Tubing Kinking & Flow Restriction

Our compound produces flexible tubing with excellent kink resistance, maintaining consistent fluid flow rates even under bending and compression during clinical use.

🔶Cloudy & Hazy Tubing Affecting Visual Inspection

High-clarity formulation achieves haze below 5%, enabling clear visual monitoring of fluid flow, air bubbles, and medication delivery during medical procedures.

🔶Sterilization Discoloration & Property Loss

Our compound maintains color stability and mechanical properties after ETO, Gamma, and autoclave sterilization, ensuring product integrity throughout the sterilization cycle.

🔶Regulatory Compliance & Extractables Concerns

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.

🔶Proven Quality Control

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.

· Application

Small Boss

🔶IV Infusion & Transfusion Sets

Extruded clear tubing for IV infusion sets, transfusion sets, and drip chambers requiring high clarity, flexibility, and consistent flow rate performance.

🔶Blood Collection & Storage Bags

Flexible PVC sheets for blood bags, plasma bags, and transfer packs requiring excellent transparency, low extractables, and long-term stability.

🔶Catheters & Drainage Tubing

Medical-grade tubing for urinary catheters, drainage systems, and enteral feeding tubes requiring kink resistance, biocompatibility, and patient comfort.

🔶Oxygen Masks & Respiratory Devices

Injection-molded oxygen masks, nasal cannulas, and resuscitator bags requiring soft touch, transparency, and odor-free performance.

🔶Specialty Profiles

Custom extruded profiles for specialized applications in industrial and commercial settings.

🔶Custom Formulations

Tailored compounds developed to meet specific customer requirements for hardness, color, and processing characteristics.

Medical-grade PVC IV infusion and transfusion sets with ISO 10993 certification

IV Infusion & Transfusion Sets

DEHP-free PVC catheters and drainage tubing for healthcare

Catheters & Drainage Tubing

Medical PVC extrusion with SmallBoss biocompatible compound

Specialty Profiles

· Why Choose Us

Small Boss

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.

30+ Years Experience

PVC Modification Technology

72,000 MT/Year

Production Capacity

100+ Countries

Global Export Coverage

OEM/ODM Available

Custom Formulations

Ready to Upgrade Your Medical Grade Compound Supply Chain?

Get Free Samples & Technical Consultation

Email: zt02@smallboss.com | Website: www.ztsmallboss.com

★ Premium Medical Grade Compound Supplier ★

 

30+ Years PVC Modification Technology · ISO Certified Manufacturer

Export to 120+ Countries Worldwide · SGS, Intertek, Bureau Veritas Verified

Product Overview

Small Boss

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.

· Specification

Small Boss
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

· Advantage

Small Boss

🔶Tubing Kinking & Flow Restriction

Our compound produces flexible tubing with excellent kink resistance, maintaining consistent fluid flow rates even under bending and compression during clinical use.

🔶Cloudy & Hazy Tubing Affecting Visual Inspection

High-clarity formulation achieves haze below 5%, enabling clear visual monitoring of fluid flow, air bubbles, and medication delivery during medical procedures.

🔶Sterilization Discoloration & Property Loss

Our compound maintains color stability and mechanical properties after ETO, Gamma, and autoclave sterilization, ensuring product integrity throughout the sterilization cycle.

🔶Regulatory Compliance & Extractables Concerns

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.

🔶Proven Quality Control

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.

· Application

Small Boss

🔶IV Infusion & Transfusion Sets

Extruded clear tubing for IV infusion sets, transfusion sets, and drip chambers requiring high clarity, flexibility, and consistent flow rate performance.

🔶Blood Collection & Storage Bags

Flexible PVC sheets for blood bags, plasma bags, and transfer packs requiring excellent transparency, low extractables, and long-term stability.

🔶Catheters & Drainage Tubing

Medical-grade tubing for urinary catheters, drainage systems, and enteral feeding tubes requiring kink resistance, biocompatibility, and patient comfort.

🔶Oxygen Masks & Respiratory Devices

Injection-molded oxygen masks, nasal cannulas, and resuscitator bags requiring soft touch, transparency, and odor-free performance.

🔶Specialty Profiles

Custom extruded profiles for specialized applications in industrial and commercial settings.

🔶Custom Formulations

Tailored compounds developed to meet specific customer requirements for hardness, color, and processing characteristics.

Medical-grade PVC IV infusion and transfusion sets with ISO 10993 certification

IV Infusion & Transfusion Sets

DEHP-free PVC catheters and drainage tubing for healthcare

Catheters & Drainage Tubing

Medical PVC extrusion with SmallBoss biocompatible compound

Specialty Profiles

· Why Choose Us

Small Boss

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.

30+ Years Experience

PVC Modification Technology

72,000 MT/Year

Production Capacity

100+ Countries

Global Export Coverage

OEM/ODM Available

Custom Formulations

Ready to Upgrade Your Medical Grade Compound Supply Chain?

Get Free Samples & Technical Consultation

Email: zt02@smallboss.com | Website: www.ztsmallboss.com

      

      

    

    

    

    


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