ISO 13485 Certified Manufacturer

    Isolation Gowns for ICUIntensive Care Unit

    As a leading manufacturer, Medtecs provides AAMI Level 2, 3, and 4 isolation gowns engineered for the variable-risk environment of the ICU. Partner directly with us for reliable, compliant, high-performance PPE solutions.

    AAMI PB70 Compliant
    FDA 510(k) Cleared
    30+ Years Experience

    Why the ICU Demands a Multi-Level Gown Strategy

    The ICU is not a single-risk environment. A Critical Care Nurse may perform a low-risk blood draw one moment and assist in a high-risk intubation the next.

    2

    AAMI Level 2

    For low-to-moderate risk tasks like blood draws, managing sutures, or care in outpatient clinics.

    IL-2025YTU
    3

    AAMI Level 3

    For moderate fluid exposure such as arterial line placement or managing drains where fluid splashes are anticipated.

    IL-0023BTU
    4

    AAMI Level 4

    Non-negotiable for high-risk procedures like intubation and dealing with emerging infectious diseases or multidrug-resistant bacteria.

    IL-4063WKTP

    Understanding AAMI PB70 Standards

    This tiered approach ensures your infection prevention program differentiates its response based on the scenario—from managing body fluids to responding to trauma cases. Our goal is to empower your Infection Control team with the knowledge to make the right choice every time.

    Application Scenarios: Matching the Gown to the ICU Task

    Clear, scenario-based guidance to help hospital staff select the right gown for specific clinical tasks.

    Critical Care (ICU) Nurse

    For the Critical Care Nurse: Absolute Barrier Reliability

    Scenario: You are performing a high-fluid procedure (e.g., intubation) on an infectious patient. You need absolute confidence in your PPE and must prevent wrist exposure from sleeve ride-up.

    Key Pain Points:

    • • Needs absolute confidence in barrier protection
    • • Fears glove-gown interface failure (sleeve ride-up)
    • • Needs comfort and breathability for long shifts
    Recommended: AAMI Level 4 (IL-4063WKTP) & Level 2 (IL-2025YTU)

    Modern ICU Setting

    Infection Control Specialist

    For the Infection Control Specialist: Verifiable Compliance

    Scenario: You are conducting a risk assessment for the ICU and need to create a clear protocol, ensuring purchased gowns are 100% compliant with AAMI/ASTM standards.

    Key Pain Points:

    • • Ensuring all PPE meets and exceeds stated AAMI/ASTM standards
    • • Standardizing PPE to reduce user error
    • • Training staff on correct gown selection for specific risks
    Solution: Multi-Level Gown Portfolio with Full Documentation

    Compliance Documentation

    Hospital Procurement Manager

    For the Procurement Manager: A Resilient Supply Chain

    Scenario: You are securing a reliable supply of critical gowns (L2 through L4) for the next 6-12 months. You fear stockouts during demand surges and must audit vendor reliability.

    Key Pain Points:

    • • Supply chain stability (fears stockouts)
    • • Auditing vendors to ensure reliability (ISO 13485 certified)
    • • Balancing unit cost vs. total cost of ownership
    Solution: Manufacturer-Direct Partnership

    Supply Chain Management

    Uncompromising Compliance & Quality Assurance

    In the ICU, there is no room for error. Trust is earned with transparency and proof.

    AAMI PB70 & ASTM F1671

    Our protective gowns are rigorously tested to meet or exceed ANSI/AAMI PB70 standards for liquid barrier performance and ASTM F1671 for viral penetration resistance.

    ISO 13485 & FDA 510(k)

    Manufactured in our ISO 13485 certified facilities. Our medical gowns are cleared as Class II medical devices via FDA 510(k) premarket approval.

    Certified & Trusted Worldwide

    FDA Registered
    CE Mark
    ISO 13485
    AAMI Certified
    ASTM Compliant

    Your Resilient PPE Partner

    A manufacturer-direct supply chain you can trust, backed by 30+ years of experience

    Global Manufacturing

    Robust infrastructure across multiple facilities ensures uninterrupted supply

    Scalable Production

    Meet the demands of large hospital networks and government tenders

    Direct Partnership

    Eliminate intermediaries for competitive pricing and transparent communication

    Ready to Partner with Us?

    Contact our specialists today to discuss your ICU’s specific needs, request technical data sheets, or order a sample pack for evaluation by your team.

    © 2024 Medtecs International Corporation Ltd. All rights reserved. | ISO 13485 Certified Manufacturer

     

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