AAMI Level 4 Certified|FDA 510(k) Cleared

    AAMI Level 4 Microporous Laminate Isolation Gown Manufacturer

    Breathable Viral Barrier with Taped Seams. Engineered for high-stakes healthcare environments with advanced microporous film technology that passes rigorous ASTM F1671 and ASTM F1670 tests.

    Liquid-Proof Protection
    Breathable Design
    Taped Seams
    Trusted by healthcare facilities worldwide • ISO 9001 & ISO 13485 Certified

    The Science of Microporous Protection

    Understanding material science is critical in procurement. Standard PE-coated gowns create a “sauna effect.” Our Microporous laminate coating solves this.

    How Selective Permeability Works

    Virus Blocker

    Pores are smaller than liquid molecules and microorganisms, creating a physical wall against ASTM F1671 viral penetration.

    Vapor Vent

    Pores are larger than water vapor molecules. Perspiration evaporates and escapes, regulating body temperature and reducing heat stress.

    Result: Maximum protection with minimal discomfort

    Material Comparison

    Material
    Protection
    Breathability
    Microporous
    (Our Technology)
    Level 4
    High
    SMS
    (Standard)
    L3
    Level 3
    Good
    PE Coated
    (Basic)
    Level 4
    Poor
    Only Microporous delivers Level 4 with breathability

    Application Scenarios: Level 4 Gowns for Your Specific High-Risk Environment

    Different high-risk environments demand specific protection strategies. Explore which Level 4 gown configuration best suits your operational needs.

    ICU/ER Nurses

    For Unknown Risks and High Fluid Exposure

    Frontline nurses in the ICU and Emergency Room face unpredictable threats—unknown pathogens, high-volume blood and fluid exposure during trauma cases, and intubation aerosols. In these chaotic environments, there’s no time to assess risk. You need immediate, reliable barrier protection. Our IL-4036YKTP Lightweight model provides AAMI Level 4 defense that has passed ASTM F1671 (Viral Penetration) testing, ensuring that even during the most intense resuscitation, you remain protected without overheating.

    Recommended: IL-4036YKTP (Lightweight)

    For Unknown Risks and High Fluid Exposure

    Surgeons/OR Staff

    Protecting the Sterile Field and the Team

    In the OR, the stakes are dual: protecting the patient from contamination while shielding the surgical team from exposure to infectious agents. While sterile surgical gowns are standard, non-sterile AAMI Level 4 isolation gowns are critical during certain high-risk procedures (e.g., emergency surgeries on infectious patients) or in hybrid operating rooms. Level 4 gowns act as an additional barrier, reducing the risk of surgical site infections (SSIs) and safeguarding the team when handling contaminated tissues or fluids.

    Protecting the Sterile Field and the Team

    Decontamination Staff

    For Durability Against Chemical & Biological Hazards

    Decontamination personnel work in the ‘hot zone,’ exposed to prolonged contact with high concentrations of biohazards, cleaning chemicals, and contaminated surfaces. Your gown must withstand not just viral threats but also the physical rigors of scrubbing, lifting, and maneuvering equipment. Our IL-4063WKTP Heavy-Duty model, at 63gsm, is engineered for maximum durability. It resists tearing and offers enhanced resistance to liquid chemical permeation (ASTM F739-12 compliant), keeping you safe while you restore safety for others.

    Recommended: IL-4063WKTP (Heavy-Duty)

    For Durability Against Chemical & Biological Hazards

    Biosafety Lab Researchers

    Containment in BSL-3/4 Environments

    Working with high-consequence pathogens in BSL-3 and BSL-4 labs requires absolute barrier integrity. A single breach could be catastrophic. Medtecs AAMI Level 4 gowns are designed as part of an ensemble PPE system (often paired with PAPRs) to create multiple layers of defense. Our microporous film laminate fabric has been rigorously tested to ASTM F1671 standards, ensuring that even at the microscopic level, viruses cannot penetrate. When containment is non-negotiable, Medtecs provides the assurance of total protection.

    Containment in BSL-3/4 Environments

    Product Specifications & Manufacturing Excellence

    Detailed specifications designed for security, comfort, and compliance. Built for supply chain directors and risk managers who demand verifiable quality.

    Designed for Security and Comfort

    Knitted Cuffs

    Soft, elasticated knit cuffs provide a secure seal with gloves, preventing fluid wicking at the wrist—a critical vulnerability point.

    Full Frontal Coverage

    Over-the-head gown style with tie-neck design ensures complete anterior protection, eliminating gaps that compromise safety.

    Secure Fit System

    Features waist ties and neck closures engineered to keep the gown securely in place during active medical procedures.

    Breathable Comfort

    The nonwoven spunbond inner layer combined with microporous technology ensures comfort even during extended wear, reducing heat stress.

    Verifiable Compliance & Quality

    FDA 510(k)
    Cleared
    AAMI Level 4
    Certified
    ISO 9001
    Quality System
    ISO 13485
    Medical Devices

    Manufacturer-Direct Stability

    Avoid broker volatility with stable bulk supply from a global leader

    Testing Standards Compliance

    ASTM F1671
    Viral Penetration Resistance
    ASTM F1670
    Synthetic Blood Resistance
    ASTM F739-12
    Chemical Permeation Resistance
    ✓ Sourcing non-compliant PPE is a liability. Medtecs guarantees verifiable compliance.

     

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