AAMI Level 2 Isolation Gown Manufacturer

    As a leading global manufacturer of certified PPE, Medtecs provides high-quality, compliant AAMI Level 2 isolation gowns designed for modern healthcare. Reliable, cost-effective protection directly from the source.

    AAMI Level 2 Explained: Your Guide to Compliance

    Understanding AAMI standards is the foundation of staff safety and facility compliance

    What is the ANSI/AAMI PB70 Standard?

    The ANSI/AAMI PB70:2012 standard is the FDA benchmark for classifying surgical and isolation gown barrier performance, establishing a clear 1-4 level system from minimal to high risk protection.

    The Specifics of Level 2 Barrier Performance

    Level 2 gowns must pass two critical tests:
    • AATCC 42
      Impact Penetration (light splashes)
    • AATCC 127
      Hydrostatic Pressure (fluid pressure)

    Level 2 vs. Level 1: Making the Right Choice

    Level 1 is for minimal risk (visitor use, basic care). Level 2 provides higher barrier protection for clinical situations with potential fluid contact—the compliant choice for phlebotomy, ICU work, and standard precautions.

    Medtecs’ Commitment: Our Certifications

    Our facilities are FDA registered, CE marked, and ISO 13485 certified— your assurance of a stringent Quality Management System for medical devices.

    Featured Product

    Product Deep Dive: The IL-2025YTU SMMS Gown

    Engineered to address the most common clinical complaints: discomfort and barrier failure

    IL-2025YTU Key Specifications

    ModelIL-2025YTU
    AAMI Level
    Level 2
    Material100% 4-Ply SMMS (25gsm)
    SeamsUltrasonic Welded
    FeaturesThumb Loops, Over-the-Head, Tie-Back
    ColorYellow
    SizeRegular (Universal Fit)
    ComplianceAATCC 42, AATCC 127
    Packaging100 pcs/carton

    Breathable SMMS Fabric

    4-ply SMMS (25gsm) provides superior breathability compared to PE-coated gowns. Keeps staff cooler during long shifts, reducing heat stress.

    Thumb Loops

    Integrated thumb loops anchor the sleeve, preventing dangerous “sleeve ride-up” and ensuring a secure, gap-free seal with gloves.

    Ultrasonic Seams

    No needle holes, no thread. Ultrasonic bonding creates stronger, more impervious seams that are low-linting and ideal for clinical environments.

    AAMI Level 2 Solutions for Your Role & Environment

    Different roles and environments have unique protection needs

    By Healthcare Role

    Hospital Procurement Manager

    Balancing Budget with Clinical Quality

    Responsible for sourcing compliant, cost-effective PPE while ensuring stable supply chain. Key challenges include balancing budget constraints with clinical demands, ensuring AAMI Level 2 compliance, and avoiding supply disruptions.
    Budget vs. quality balance
    Full compliance verification
    Supply chain stability

    Clinical Nurse (ICU, ER, General Ward)

    Comfort and Protection for Long Shifts

    Frontline staff requiring reliable protection that’s comfortable for extended wear and functional during active procedures. Critical needs include preventing sleeve ride-up, reducing heat stress, and quick donning for emergencies.
    Sleeve ride-up issues
    Heat stress from plastic gowns
    Rapid donning needs
    Recommended: IL-2025YTU with Thumb Loops

    Infection Control Specialist

    Minimizing Healthcare-Associated Infections

    Setting hospital-wide protocols and evaluating PPE to minimize HAIs. Focus on gown-to-glove interface integrity, seam quality without needle holes, and ensuring correct AAMI level selection.
    Gown-glove interface failures
    Stitched seam vulnerabilities
    Protocol compliance

    Laboratory / Research Manager

    Protecting Staff and Samples

    Managing clean environments where PPE must protect staff from specimens while protecting samples from contamination. Requires low-linting materials, splash protection, and secure sleeve seals.
    Lint contamination
    Specimen splash risk
    Secure sleeve seal
    Recommended: IL-2025YTU with Ultrasonic Seams

    Dental / Outpatient Clinic Director

    Cost-Effective Protection for High Volume

    Fast-paced environment requiring cost-effective, reliable protection against splashes and aerosols. Need bulk pricing, aerosol/splash barriers, and rapid donning/doffing.
    High-volume cost pressure
    Aerosol generation
    Fast patient turnover

    By Clinical Scenario

    Low-to-Moderate Risk Procedures

    Phlebotomy, Dialysis, IV Placement

    Clinical tasks where fluid splashes from bloodborne pathogens are possible. Requires protection meeting AATCC 42 & 127 while maintaining staff comfort.

    Recommended: IL-2025YTU

    Low-to-Moderate Risk Procedures

    Solving ‘Sleeve Ride-Up’ in ICU/ER

    Active Clinical Settings

    Active settings (ER, ICU) where staff movement creates gown-to-glove gaps. Requires secure interface to prevent wrist exposure and infection control breaches.

    Recommended: IL-2025YTU with Thumb Loops

    Solving ‘Sleeve Ride-Up’ in ICU/ER

    Laboratory & Clean Environments

    Research & Pharmacy Compounding

    Lab research or pharmacy where staff need protection from specimens while sensitive samples need protection from lint. Requires no-thread, pinhole-free construction.

    Recommended: IL-2025YTU with Ultrasonic Seams

    Laboratory & Clean Environments

    Dental & Aerosol-Generating Settings

    Dental, Veterinary Procedures

    Dentists and vets needing lightweight, breathable barriers against aerosols and splashes during cleanings or procedures. Requires heat stress reduction.

    Recommended: IL-2025YTU

    Dental & Aerosol-Generating Settings

    Partner with a Global PPE Manufacturer

    Over 30 years of experience safeguarding healthcare institutions worldwide

    Download Our Full PPE Catalog

    Explore our complete range of certified medical apparel, including AAMI Level 1, 3, and 4 gowns, surgical gowns, coveralls, face masks, and nitrile gloves.

    Download Test Reports & Compliance Data

    Access technical data sheets, instructions for use, and AAMI compliance certificates (AATCC 42/127) for your Value Analysis Committee.

    Why Partner with Medtecs?

    Founded in 1989, Medtecs is more than a supplier—we’re a partner in “Safeguarding Every Tomorrow” with medical-grade PPE solutions delivered with speed, warmth, and care.
  1. Global footprint across North America, Europe, and Asia
  2. ISO 13485 certified, FDA registered manufacturing
  3. Largest medical PPE capacity in Southeast Asia
  4. Frequently Asked Questions

    Quick answers to common questions about AAMI Level 2 isolation gowns

    Yes! For bulk orders, we can accommodate custom specifications including different sizes, colors, and packaging options. Contact our B2B team to discuss your specific requirements and minimum order quantities.
    © 2024 Medtecs International Corporation. All rights reserved. Founded 1989 | ISO 13485 Certified | FDA Registered

     

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