QJ210A Universal Testing Machine for Latex Glove Tensile Strength Testing

Overview

The QJ210A Universal Testing Machine is an electromechanical tensile testing system engineered for precise mechanical characterization of thin elastomeric medical products—particularly natural rubber latex gloves—within a 5 kN load capacity. It operates on the principle of controlled uniaxial force application via a servo-driven crosshead, measuring real-time load, displacement, and strain response in accordance with standardized tensile protocols defined in ISO 37, ASTM D412, and YY/T 0613–2014 (Chinese standard for medical gloves). Unlike legacy hydraulic or manual testers, the QJ210A integrates closed-loop digital servo control, enabling consistent strain-rate compliance and high reproducibility across repeated test cycles. Its modular frame architecture supports rapid fixture reconfiguration for multi-mode mechanical evaluation—including tensile strength, elongation at break, tear resistance (ASTM D624), puncture resistance (ISO 22313), peel adhesion (ASTM D903), and shear deformation—making it suitable for both QC laboratories and R&D environments in medical device manufacturing, PPE certification bodies, and regulatory testing labs.

Key Features

• High-accuracy force measurement with 0.5-class calibration traceable to national metrology institutes; full-scale resolution of 500,000 counts ensures stable sensitivity across the entire 5 N–5,000 N range without auto-ranging artifacts.
• Dual-speed crosshead actuation (fast jog + fine-tune mode) with programmable speed profiles from 0.01 to 500 mm/min, meeting ISO 527–1 and ASTM D882 requirements for low-strain-rate elastomer testing.
• Integrated digital display panel showing real-time force (N/kN), displacement (mm), and stress–strain curve visualization—enabling immediate operator verification prior to data export.
• Robust structural design featuring extruded aluminum enclosure with industrial-grade powder coating, minimizing thermal drift and mechanical resonance during dynamic loading.
• Comprehensive safety architecture: electronic limit switches, software-based overload cutoff (110% FS), automatic return-to-start function post-test, and dual-mode emergency stop (hardware + firmware).
• Modular fixture interface compatible with ISO-standard pneumatic, wedge, and pin-type grips—customizable for flat glove strips, finger-tip specimens, or rolled cuff sections per EN 455–2.

Sample Compatibility & Compliance

The QJ210A accommodates specimens conforming to standard glove test geometries defined in ISO 4074 (natural rubber latex surgical gloves) and ASTM D3577 (general-purpose rubber gloves). Specimen widths up to 150 mm and gauge lengths up to 800 mm allow full-thickness tensile evaluation of cut strips (typically 6 mm wide × 25 mm gauge length) as well as whole-finger burst tests. All mechanical outputs comply with GLP documentation requirements: raw force/displacement time-series data are timestamped, digitally signed, and stored with audit trail metadata. The system supports validation against ISO/IEC 17025 clause 6.4.10 (equipment verification), and its force transducer is certified per ISO 376:2011 Class 0.5. Test reports generated meet FDA 21 CFR Part 11 electronic record integrity criteria when paired with compliant PC software and user access controls.

Software & Data Management

The QJ210A interfaces with Windows-based testing software (v3.2+) supporting ASTM E4, ISO 179-1, and GB/T 228.1–2021 test method templates. Software features include automated parameter sequencing (pre-set ramp-hold-break cycles), real-time curve overlay comparison, statistical batch reporting (mean, SD, CV%, min/max), and export to CSV, PDF, or XML formats. Data encryption, user-level permissions (admin/operator/viewer), and electronic signature capture satisfy GMP Annex 11 and EU GMP Chapter 4 requirements. Optional integration with LIMS platforms via OPC UA or TCP/IP enables direct result ingestion into enterprise quality databases without manual transcription.

Applications

• Tensile strength and ultimate elongation testing of medical-grade latex, nitrile, and vinyl gloves per ISO 4074 and YY/T 0613.
• Puncture resistance assessment using conical or needle-type probes per ISO 22313 and ASTM F1342.
• Peel strength measurement of laminated glove cuffs or coated surfaces per ASTM D903.
• Quality conformance screening for incoming raw material (latex concentrate viscosity, film casting consistency) and finished goods release.
• Stability studies evaluating aging effects (thermal/UV/ozone exposure) on mechanical integrity over shelf life.
• Regulatory submission support for FDA 510(k), CE Marking (MDR Annex II), and NMPA registration dossiers.

FAQ

What standards does the QJ210A support out-of-the-box?
Preloaded test methods include ISO 37, ASTM D412, ISO 4074, YY/T 0613–2014, GB/T 528–2009, and EN 455–2. Custom method creation is enabled via script-based configuration.
Can the system be validated for ISO/IEC 17025 accreditation?
Yes—the machine includes factory calibration certificates (traceable to NIM, China), uncertainty budgets per ISO/IEC 17025:2017 Annex A.3, and IQ/OQ documentation templates.
Is third-party software required for FDA 21 CFR Part 11 compliance?
No. The native software provides role-based login, electronic signatures, audit trails, and data immutability—fully compliant when deployed on validated IT infrastructure.
What maintenance is recommended for long-term accuracy?
Annual recalibration of the load cell and displacement encoder is advised; routine verification using certified reference weights (Class M1) and gauge blocks (ISO 3651) should occur before each shift.
Does the system support automated specimen loading?
Not natively—but the open RS-232/USB/Ethernet API allows integration with robotic sample handlers or conveyor-fed indexing stages via custom PLC interfacing.