AAMI Level 4 Certified

    Isolation Gowns for Decontamination

    AAMI Level 4 Taped Seam Viral Barrier PPE
    Medtecs, as a vertical manufacturer, supplies Class II medical device isolation gowns featuring heat-sealed taped seams. Passing ASTM F1671 viral penetration tests for zero leakage in CSSD and high-risk isolation environments. Waterproof, breathable, and single-use protection for maximum safety.
    FDA 510(k)
    Class II Device
    ASTM F1671
    Viral Barrier
    ANSI/AAMI PB70
    Level 4 Certified
    Verified Standards

    The Ultimate Barrier: Verified AAMI Level 4 & ANSI/AAMI PB70 Compliance

    In high-risk health care settings, especially ICUs and decontamination areas, only the highest Protection Levels suffice. Medtecs gowns are engineered to meet and exceed the rigorous ANSI/AAMI PB70 Level 4 standard for liquid barrier performance.

    ASTM F1671 Certified

    The Gold Standard for Viral Defense and Blood Borne Pathogens

    Viral Penetration Test verified

    Blocks microscopic microorganisms

    Protection against emerging infectious diseases

    Chemical Compatibility

    Enzymatic Resistance for Device Reprocessing

    Resistant to aggressive detergent cleaning solutions

    High-pH enzymatic presoak compatible

    Prevents chemical burns and contact dermatitis

    AAMI Level 4

    Why Level 4 is Required for Decontamination

    Highest standard for massive fluid exposure

    Superior strikethrough resistance guaranteed

    Level 2/3 inadequate for CSSD protocols

    Understanding AAMI Protection Levels

    LevelApplication RiskFluid ExposureCSSD Suitable
    Level 1Minimal riskLight sprayNo
    Level 2Low riskSome sprayNo
    Level 3Moderate riskModerate splashNo
    Level 4High riskMassive uncontrolled fluid✓ Required
    Zero-Leakage Engineering

    Taped Seams & Robust Fabric Properties

    The integrity of an Isolation Cover Gown is defined by its weakest point: the seams. Our design eliminates this risk entirely, ensuring strikethrough resistance and zero fluid transmission.

    Magnified view: Heat-sealed taped seam vs. traditional stitched seam

    Heat-Sealed Taped Seams

    To achieve true Level 4 compliance, every inch of stitching is sealed using specialized heat-sealed tape. This process fills the microscopic needle holes created during assembly, creating a continuous, fused barrier.
  1. Absolute strikethrough resistance
  2. Protects against pressurized water spray
  3. Zero fluid transmission guarantee
  4. High-Tensile Strength & Full-Back Design

    Our Full-Back Isolation Gowns utilize Spunbond Polypropylene for exceptional high-tensile strength, resisting tears and punctures during heavy lifting and active movement.
  5. 360-degree barrier protection
  6. Eliminates open-back exposure risk
  7. Superior dexterity for critical procedures
  8. Microporous Laminate

    Spunbond Polypropylene + PE Film for maximum barrier with breathability

    AATCC 127 Tested

    Hydrostatic pressure resistance exceeds 120 cm H₂O

    Knit Cuffs

    Extended elastic wrists for secure glove interface and zero ride-up

    Rigorous Quality Control

    Beyond Compliance: FDA Class II Status & In-House QC

    As a global manufacturer, Medtecs controls the critical assembly process to guarantee quality, offering traceability and QC verification that trading companies cannot match.

    Batch-Level Testing & Traceability

    Every production run undergoes rigorous verification for absolute quality assurance

    AATCC 127 Hydrostatic Testing

    Random samples from every batch tested for seam integrity and liquid barrier performance

    Raw Material Traceability

    QC checks on incoming PE film laminate to ensure uniformity and meet hospital risk management requirements

    Seam Taping Quality Control

    100% visual inspection of heat-sealed tape application before packaging

    FDA 510(k) Clearance Documentation

    Complete compliance documentation for tender evaluation and procurement

    Class II Medical Device

    Strict adherence to 510(k) clearance standards with full regulatory compliance

    Technical Data Sheets (TDS)

    Complete product specifications, test results, and certification documentation

    Certificate Requests

    Dedicated customer service for all compliance documentation and certificate requests

    3-Step Quality Control Process

    1

    Incoming Film QC

    PE film laminate tested for thickness, uniformity, and barrier properties

    2

    Seam Taping QC

    Visual and tactile inspection of every heat-sealed seam for continuity

    3

    Batch Hydrostatic Test

    AATCC 127 pressure testing on random samples from completed production run

    Worker-Centric Design

    Ergonomics & Comfort: Addressing Healthcare Worker Fatigue

    We address the major pain point of heat stress in impervious PPE. High humidity combined with necessary protective gowns can lead to dangerous fatigue. Medtecs focuses on human-centric design.

    High MVTR: Microporous Barrier for Comfort

    Breathability without compromising protection

    We utilize Microporous Laminate technology to achieve a high MVTR (Moisture Vapor Transmission Rate). The porous structure of the Polyethylene film is specifically engineered to block bulk fluid while allowing moisture vapor (sweat) to escape.

    How Microporous Technology Works

    Water molecules blocked: Bulk liquid cannot penetrate the microporous structure

    Water vapor escapes: Smaller vapor molecules pass through pores, reducing heat stress

    Enhanced compliance: Worker comfort leads to proper PPE usage and focus

    vs. Poly-Coated Alternatives: Traditional poly-coated fabrics trap all moisture, creating unbearable heat buildup during extended wear.

    Ergonomic Fit, Knit Cuffs & Securement

    Optimized for unrestricted movement and continuous protection

    The generous cut of our Full-Back Isolation Gowns is optimized for dexterity and unrestricted movement during active clinical work. The knit cuffs (elastic wrists) are extended and reinforced to ensure a secure interface.

    Extended Knit Cuffs

    Reinforced elastic wrists extend 3+ inches to ensure secure, sealed interface with gloves, preventing sleeve ride-up and maintaining continuous barrier

    Full-Back Design

    360-degree coverage eliminates the exposure risk associated with open-back protective gowns, critical for bending and reaching movements

    Dexterity Optimized

    Ergonomic sleeve cut allows full range of motion for instrument handling, patient care, and equipment operation without restriction

    The Comfort-Protection Balance

    Low MVTR Gowns

    Heat stress, fatigue, reduced compliance, safety risks

    Moderate MVTR

    Some comfort improvement but may not meet Level 4 requirements

    High MVTR (Medtecs)

    Maximum comfort + Level 4 protection = optimal worker performance

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

    Different medical environments demand different protection levels. Discover which AAMI Level 4 gown configuration best matches your specific workplace risks and operational requirements.

    ICU/ER Nurses

    For Unknown Risks and High Fluid Exposure

    Frontline ICU and Emergency Room nurses face unpredictable pathogen exposure during trauma cases, intubations, and high-acuity patient care. When confronted with unknown infectious risks and potential high-volume fluid exposure, AAMI Level 4 barrier protection becomes essential. The IL-4036YKTP model offers immediate, reliable protection with ASTM F1671 viral barrier compliance, ensuring nurses can focus on critical patient care without compromising their own safety in these high-stakes environments.

    Recommended: IL-4036YKTP (Lightweight)

    For Unknown Risks and High Fluid Exposure

    Surgeons/OR Staff

    Protecting the Sterile Field and the Team

    Operating room personnel require absolute barrier protection to maintain the sterile field during surgical procedures. While many surgical gowns are sterile, AAMI Level 4 non-sterile gowns play a crucial role in high-risk surgeries involving infected patients, emergency procedures, or cases with anticipated heavy fluid exposure. These gowns provide comprehensive protection against cross-contamination and surgical site infection (SSI) risks, safeguarding both the surgical team and patient outcomes during complex operations.

    Protecting the Sterile Field and the Team

    Decontamination Staff

    For Durability Against Chemical & Biological Hazards

    Decontamination personnel face prolonged exposure to high concentrations of biohazardous materials and aggressive cleaning chemicals during instrument reprocessing and facility sanitation. This demanding environment requires exceptional durability and chemical resistance. The heavy-duty IL-4063WKTP model, constructed with 63gsm reinforced material, delivers superior tear resistance and extended wear time. Its robust construction withstands the rigors of manual scrubbing, chemical exposure, and physical stress inherent in decontamination protocols.

    Recommended: IL-4063WKTP (Heavy-Duty)

    For Durability Against Chemical & Biological Hazards

    Biosafety Lab Researchers

    Containment in BSL-3/4 Environments

    Researchers working with high-consequence pathogens in Biosafety Level 3 and 4 laboratories operate under the strictest containment protocols. In these environments, absolute barrier integrity is not optional—it is a critical safety requirement that can prevent catastrophic breaches. AAMI Level 4 gowns serve as a fundamental component of the ensemble PPE system, typically worn in conjunction with PAPRs and additional protective layers. The verified ASTM F1671 compliance provides essential assurance of total protection against viral transmission in these maximum-security research settings.

    Containment in BSL-3/4 Environments

    Technical Details

    Technical Specifications & Strategic Partnership

    Complete product details and manufacturer commitment for healthcare facilities and supply chain managers

    Product Specifications (Non-Sterile, Single-Use)

    Product TypeDisposable Isolation Gowns (Single-use, Non-Sterile)
    ModelsIL-4063WKTP (White) / IL-4036YKTP (Yellow)
    Material CompositionSpunbond Polypropylene + Polyethylene Film (Microporous Laminate)
    Seam TechnologyHeat-Sealed Taped Seams (Zero Leakage Engineering)
    Standard ComplianceANSI/AAMI PB70 Level 4, ASTM F1671, ASTM F1670, AATCC 127
    Design FeaturesFull-Back Isolation Gowns, Knit Cuffs (Elastic Wrists), Extended Sleeves
    Closure SystemNeck tie and waist tie for secure fit
    Sizes AvailableUniversal (One Size Fits Most), Large, Extra Large
    Regulatory StatusFDA 510(k) Cleared – Class II Medical Device
    Packaging10 pieces/bag, 100 pieces/carton (Flat Pack)

    Efficient Logistics

    Our flat pack packaging (10 pieces/bag, 100 pieces/carton) is optimized for inventory and stockpile management
    • • Compact storage footprint
    • • Easy inventory counting
    • • Efficient warehouse space utilization

    Global Distribution

    Established logistics network ensures timely delivery of protective equipment PPE worldwide
    • • Strategic warehouse locations
    • • Express shipping options available
    • • Customs documentation support

    Vertical Integration

    Total quality control from specialized barrier film to finished taped gown
    • • Transparent quality indicators
    • • Reliable medical textiles
    • • Consistent batch-to-batch quality

    Ready to Source AAMI Level 4 Protection?

    Download our complete Technical Data Sheet (TDS) with full specifications, test results, and 510(k) clearance documentation. Our customer service team is ready to assist with certificate requests and procurement support.

    Volume pricing available for hospitals, GPOs, and distributors

    Partner with a Trusted Medical Gowns Supplier

    Medtecs delivers verified AAMI Level 4 protection with transparent quality control, complete regulatory compliance, and dedicated customer service. Experience the difference of working directly with the manufacturer.
    24/7
    Technical Support
    100%
    Batch Testing
    Level 4
    AAMI Certified
    Serving hospitals, GPOs, distributors, and healthcare facilities worldwide since 1989

    © 2025 Medtecs International Corporation. All rights reserved. | Manufacturer of FDA-Cleared AAMI Level 4 Isolation Gowns

    IL-4063WKTP | IL-4036YKTP | ASTM F1671 Certified | ANSI/AAMI PB70 Level 4 Compliant

     

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