Product Overview

 

High-performance pressure-sensitive medical adhesives engineered for skin-contact diagnostic monitors and advanced wound care. Supplied in master rolls or die-cut formats, optimized for direct inline lamination with non-wovens, polyurethane films, and foams.

 

 
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Construction and Materials

Carrier Substrates:

TPU film, hydroentangled spunlace non-woven, open-cell polyurethane foam, and perforated PE film.

Adhesive Chemistries:

Cross-linked medical acrylic and platinum-cured silicone formulations. Engineered for low-surface-energy substrate bonding.

Release Liners:

Siliconized PET film with differential release options or clay-coated glassine paper for high-speed rotary die-cutting.

Coating Weight:

30 gsm to 120 gsm with a plus or minus 5 percent tolerance.

 

 

 
 
Functional Performance

Moisture Vapor Transmission Rate:

Greater than or equal to 1500 g per square meter per 24 hours using the inverted cup method at 37 degrees Celsius and 50 percent relative humidity.

180 Degree Peel Adhesion to Stainless Steel:

12 to 25 N per 25mm tested via FTM 1.

 

Static Shear Hold Power:

Greater than or equal to 24 hours under a 1kg load with a 25mm by 25mm contact area, tested via FINAT FTM 8.

Loop Tack:

8 to 18 N per 25mm tested via FINAT FTM 9.

 

 

Silicone Double-sided Adhesive

 

Key Features

Biocompatible Matrix: Formulated to comply with ISO 10993 cytotoxicity and sensitization limits.


Atraumatic Removal: Clean peel performance with zero adhesive residue transfer or stratum corneum stripping.


Vapor Permeability: Open polymer matrix enables continuous sweat dissipation, mitigating the risk of skin maceration during long-term wear.


Sterilization Stability: Withstands Ethylene Oxide and Gamma irradiation up to 50 kGy without cross-linking degradation or discoloration.

 

Technical Specifications

 

Parameter

Test Method

Typical Value

Total Thickness

ISO 534

50 um to 180 um excluding liner

Peel Adhesion to Skin Model

ASTM D3330

3.5 to 7.5 N per 25mm

Moisture Vapor Transmission Rate

ASTM E96 Inverted Cup

1500 g per square meter per 24 hours

Cytotoxicity

ISO 10993-5

Pass Grade 0 non-cytotoxic

Skin Irritation and Sensitization

ISO 10993-10

Non-irritant and non-sensitizer

Master Roll Dimensions

Internal Quality Control

Width up to 1250mm and length up to 1000m

 

Applications

Continuous Glucose Monitors:

7-day to 14-day sensor patch fixation resistant to edge-lifting under moisture and shear stress.

ECG and Holter Monitoring:

Short-term to medium-term electrode attachment requiring rapid skin wetting and low-impedance electrical contact.

Advanced Wound Care:

Bordered silicone foam dressings and multi-layer surgical fixation tapes.

Ostomy Care:

Long-term skin barriers requiring high initial tack and moisture resistance.

 

Customization and OEM and ODM

 

Adhesion Tuning: Custom peel-force adjustment tailored to specific device backing materials such as silicone-to-skin or acrylic-to-device configurations.


Slitting and Die-Cutting: Precision slitting down to 10mm width alongside custom die-cut shapes incorporating pull-tabs and finger-lifts.


Inline Lamination: Multi-layer lamination combining absorbent wound pads, breathable films, and cushioning carrier foams in a single pass.


Cleanroom Packaging: Cleanroom slitting and individual barrier pouch packaging for automated device assembly lines.

 

 

Manufacturing and Quality Control

Cleanroom Environment: Processed in ISO Class 7 cleanrooms with automated particulate and microbial monitoring.


Slot-Die Coating: Precision slot-die systems ensuring tight grammage control and uniform coat weight across the entire 1250mm web width.


Inline Inspection: 100 percent automated optical surface inspection detecting gels, spots, and coating voids prior to rewinding.


Full Traceability: Complete lot traceability linking raw polymer resin lots to finished master roll dispatch.

Acrylic Adhesive Nonwoven Single-sided Adhesive

 

Quality and Compliance

 

 

Quality Management:

Manufactured under ISO 13485 certified quality management systems for medical device components.

 

Biological Evaluation:

Supported by comprehensive testing per ISO 10993 standards.

 

Regulatory Support:

Material Safety Data Sheets, Certificates of Analysis, and ISO 10993 test summaries available for 510k and EU MDR technical files.

 

 

 

FAQ

 

 

Q: How does the adhesive prevent skin maceration during 14-day wear?

A: The formulation features a hydrophilic, open-network polymer structure that achieves a moisture vapor transmission rate of greater than or equal to 1500 g per square meter per 24 hours. This facilitates continuous moisture vapor transmission away from the skin surface, preventing sweat entrapment and subsequent epidermal breakdown under occlusive patches.

Q: What are the engineering tradeoffs between acrylic and silicone medical adhesives?

A: Acrylic adhesives deliver high initial tack, strong shear resistance, and high cost-efficiency for 1-day to 3-day applications. Silicone adhesives offer atraumatic, pain-free removal, repositionability during application, and long-term wear safety up to 14 days on fragile or geriatric skin.

Q: Are these adhesive master rolls compatible with Ethylene Oxide and Gamma sterilization?

A: Yes. The chemical cross-linking architecture remains stable when exposed to Ethylene Oxide gas and Gamma irradiation up to 50 kGy, avoiding embrittlement, yellowing, or peel-strength degradation in final sterilized devices.

Q: What is the minimum order quantity for trial and production?

A: Standard master roll stock has a minimum order quantity of 1 roll measuring 1000m in length. For custom slit widths or specialized coating weight adjustments, the minimum order quantity is 500 square meters per specification. Research and development evaluation sample sheets measuring 300mm by 300mm are available upon request.

Q: Do you supply full ISO 10993 test reports for regulatory submissions?

A: Yes. Complete biocompatibility data packages including ISO 10993-5 cytotoxicity and ISO 10993-10 irritation and sensitization performed by GLP-accredited laboratories are provided under confidentiality or upon material purchase to support regulatory filings.

Q: What are the recommended storage conditions for master rolls prior to converting?

A: Store rolls in their original protective packaging in a climate-controlled environment at 15 degrees Celsius to 25 degrees Celsius and 40 percent to 60 percent relative humidity. Protect from direct sunlight and heat sources. Shelf life is 12 months from the date of manufacture under these conditions.

We're well-known as one of the leading medical adhesive manufacturers and suppliers in China. We warmly welcome you to wholesale high quality medical adhesive made in China here from our factory. If you have any enquiry about customized service, please feel free to email us.

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