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

Level	Application Risk	Fluid Exposure	CSSD Suitable
Level 1	Minimal risk	Light spray	No
Level 2	Low risk	Some spray	No
Level 3	Moderate risk	Moderate splash	No
Level 4	High risk	Massive 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.

•Absolute strikethrough resistance

•Protects against pressurized water spray

•Zero fluid transmission guarantee

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.

•360-degree barrier protection

•Eliminates open-back exposure risk

•Superior dexterity for critical procedures

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

Incoming Film QC

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

Seam Taping QC

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

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 Type	Disposable Isolation Gowns (Single-use, Non-Sterile)
Models	IL-4063WKTP (White) / IL-4036YKTP (Yellow)
Material Composition	Spunbond Polypropylene + Polyethylene Film (Microporous Laminate)
Seam Technology	Heat-Sealed Taped Seams (Zero Leakage Engineering)
Standard Compliance	ANSI/AAMI PB70 Level 4, ASTM F1671, ASTM F1670, AATCC 127
Design Features	Full-Back Isolation Gowns, Knit Cuffs (Elastic Wrists), Extended Sleeves
Closure System	Neck tie and waist tie for secure fit
Sizes Available	Universal (One Size Fits Most), Large, Extra Large
Regulatory Status	FDA 510(k) Cleared – Class II Medical Device
Packaging	10 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

Isolation Gowns for Decontamination

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

ASTM F1671 Certified

Chemical Compatibility

AAMI Level 4

Understanding AAMI Protection Levels

Taped Seams & Robust Fabric Properties

Heat-Sealed Taped Seams

High-Tensile Strength & Full-Back Design

Microporous Laminate

AATCC 127 Tested

Knit Cuffs

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

Batch-Level Testing & Traceability

AATCC 127 Hydrostatic Testing

Raw Material Traceability

Seam Taping Quality Control

FDA 510(k) Clearance Documentation

Class II Medical Device

Technical Data Sheets (TDS)

Certificate Requests

3-Step Quality Control Process

Incoming Film QC

Seam Taping QC

Batch Hydrostatic Test

Ergonomics & Comfort: Addressing Healthcare Worker Fatigue

High MVTR: Microporous Barrier for Comfort

How Microporous Technology Works

Ergonomic Fit, Knit Cuffs & Securement

Extended Knit Cuffs

Full-Back Design

Dexterity Optimized

The Comfort-Protection Balance

Low MVTR Gowns

Moderate MVTR

High MVTR (Medtecs)

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

ICU/ER Nurses

For Unknown Risks and High Fluid Exposure

Surgeons/OR Staff

Protecting the Sterile Field and the Team

Decontamination Staff

For Durability Against Chemical & Biological Hazards

Biosafety Lab Researchers

Containment in BSL-3/4 Environments

Technical Specifications & Strategic Partnership

Product Specifications (Non-Sterile, Single-Use)

Efficient Logistics

Global Distribution

Vertical Integration

Ready to Source AAMI Level 4 Protection?

Partner with a Trusted Medical Gowns Supplier

By Protection Level (AAMI) Isolation Gowns:

AAMI Level 1 Isolation Gowns,

AAMI Level 2 Isolation Gowns,

AAMI Level 3 Isolation Gowns,

AAMI Level 4 Isolation Gowns,

By Color Isolation Gowns:

Blue Isolation Gowns,

White Isolation Gowns,

By Sterility Isolation Gowns:

By Feature Isolation Gowns:

Isolation Gowns with Knit Cuffs,

By Material Isolation Gowns:

SMS Isolation Gowns,

PE Coated Isolation Gowns,

By Usability Isolation Gowns:

By Application / Use Case Isolation Gowns:

Isolation Gowns for ICU,

Isolation Gowns for ER & Trauma,

Isolation Gowns for Decontamination,

Catalog Download

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