Medical-Grade Thermoplastic Trays For Medical Devices

Wholesale Medical-Grade Thermoplastic Trays For Medical Devices from Shunxin, a professional manufacturer from China. Sheet thickness ranges from 0.2-1.2mm and can be selected according to the weight of the medical device. The tray can be molded according to 3D drawings or physical samples of the medical devices. Contoured cavities closely fit the device shape and provide secure positioning to prevent movement.

For sharp instruments, such as surgical scissors and puncture needles, relief structures can be incorporated into the cavities to prevent force from being applied to the tips. A sealing platform is provided around the edge of the tray, with a flat and smooth surface that can be sealed with medical-grade coated lid materials or heat-sealing films to form sterile packaging. Transparent or transparent blue-bottom options are available. Cleanliness and particulate contamination are strictly controlled during production, and the trays can be adapted to various sterilization methods, including EO, radiation, and steam. Welcome to discuss your specific requirements.

Product Advantages

✅ Medical-Grade Materials – Made from PETG/APET/PVC medical-grade sheets, non-toxic and BPA-free, complying with FDA standards.

✅ Sterile Barrier System – The tray can be heat-sealed with Tyvek® lid materials to form a sterile barrier and comply with ISO 11607 requirements for terminally sterilized medical device packaging

✅ Cleanroom Production – Manufactured in a 10,000-class (ISO Class 7) cleanroom to ensure product cleanliness and safety

✅ ISO 13485 Quality Management System Certification – Implements a dedicated quality management system for the medical device industry with full-process traceability

✅ Precision Contoured Positioning – Molds are developed based on physical device samples or 3D drawings, with cavities closely fitting the device shape for precise positioning without movement

✅ Sealing Platform Design – A sealing platform is provided around the tray edge to accommodate Tyvek® lid materials or medical-grade coated sealing films

✅ High Transparency – Clearly displays the condition of medical devices for visual inspection and barcode traceability

✅ Multiple Material Options – PETG (recommended, balanced performance) / APET (economical) / PVC (standard option)

Application Scenarios

Surgical Instrument Packaging: Sterile primary packaging for surgical instruments such as surgical forceps, scissors, tweezers, and needle holders

Injection and Puncture Device Packaging: Packaging for disposable sterile devices such as syringes, infusion sets, puncture needles, and indwelling needles

Implant Packaging: Packaging for implantable medical devices such as bone screws, bone plates, and artificial joints

Medical Consumables Packaging: Thermoformed inner trays for medical consumables such as medical catheters, guidewires, and drainage tubes

Diagnostic Device Packaging: Packaging for test kits, samplers, diagnostic tools, and other products

Aesthetic Medical Device Packaging: Packaging for aesthetic medical devices such as medical aesthetic syringes and implants

Typical Industries: Class III/Class II sterile medical device manufacturing, surgical instrument manufacturing, medical consumables manufacturing, Medical OEM/ODM

FAQ

Q1: What is the difference between medical-grade thermoformed trays and regular industrial thermoformed trays?

A: The key difference lies in compliance standards and production environments. Medical trays need to be manufactured in cleanrooms, using medical-grade sheets with ISO 10993 biocompatibility certification. Products also need to comply with the ISO 11607 sterile barrier system standard, while regular industrial trays do not have these requirements.

Q2: What are the differences between PETG, APET, and PVC? How should they be selected?

A: PETG (recommended) offers excellent thermoforming performance, high transparency, and impact resistance. It can provide complete biocompatibility verification reports and is the preferred material for thermoformed medical device packaging. APET is an economical option with good transparency and is suitable for Class II medical devices. PVC is a standard option with lower cost, but its environmental performance is inferior to PETG. PETG is recommended for Class III implants and export products.

Q3: Why do medical trays need to be manufactured in a cleanroom?

A: A 10,000-class (ISO Class 7) cleanroom can effectively control airborne particulate and microbial contamination. Medical devices directly contact the tray surface, and any particles or microorganisms may affect the sterile condition of the device or cause patient infection. A 10,000-class cleanroom is a standard configuration for medical thermoformed packaging.

Q4: Which sterilization methods can medical trays accommodate?

A: PETG material can accommodate multiple sterilization methods, including ethylene oxide (EO) sterilization, radiation sterilization (gamma/e-beam), and steam sterilization. When selecting materials, compatibility between the sterilization method and tray material should be confirmed, as some materials may experience discoloration or performance degradation under certain sterilization methods.