FDA 510(k) Cleared

ISO 13485 Certified

ASTM F1671 Compliant

AAMI Level 4 Isolation Gowns: ASTM F1671 Certified Viral Barrier Protection

Engineered for high-risk clinical environments (ICU, ER, Trauma, Decontamination). Featuring impervious microporous laminate fabric and 100% taped seams for uncompromising blood and viral barrier protection.

Understanding AAMI Level 4 – The Non-Negotiable Standard for High-Risk Environments

Level 4 is the only standard that mandates passing the ASTM F1671 viral penetration test, making it the minimum requirement for high-consequence environments. Level 3 is insufficient for viral threats.

AAMI Level 4 vs Level 3: The Critical Difference is the Viral Barrier

Level 3

Fluid Splash Protection

✓AATCC 42 & TM 127 (Fluid Splash)

✗No Viral Penetration Test

—Not verified for blood-borne pathogens or viruses

Level 4

Viral Barrier Protection

✓ASTM F1670 (Synthetic Blood Under Pressure)

✓ASTM F1671 (Viral Penetration Test)

✓Only standard verified to block viruses and blood-borne pathogens

Decoding ASTM F1671: The Rigorous Viral Penetration Test

The ASTM F1671 test uses the Phi-X174 bacteriophage (approx. 27nm) to simulate a virus under pressure. Our gowns (e.g., IL-4063WKTP) are constructed with high-integrity microporous fabric and taped seams, validated to pass this test.

SGS test reports available upon request to prove the highest level of biological protection.

ASTM F1670: Resisting High-Pressure Blood Splashes

Critical for ER and Trauma units. This test simulates the high-velocity splash of an arterial bleed. Passing this test means our Level 4 gowns can withstand sudden, high-volume exposure to blood and bodily fluids without penetration, directly mitigating the risk of occupational exposure.

Our AAMI Level 4 Solutions: Engineering, Material & Clinical Design

Every detail is engineered to eliminate failure points and ensure absolute barrier integrity during critical procedures.

100% Taped Seams

Heat-sealed tape over every single seam creates a 100% waterproof and virus-proof bond. Traditional stitched seams are full of holes – taped seams ensure seams are not a failure point.

Microporous Laminate

High-performance PPSB+PE film provides a proven, impervious barrier. Available in 63gsm (heavy-duty) and 36gsm (lightweight) with the same Level 4 viral barrier protection.

Secure Knit Cuffs

Soft, secure knit cuffs provide a comfortable 360-degree seal. They stay in place under gloves and during movement, eliminating dangerous exposure gaps at the wrist.

Critical Technology: Why Taped Seams are Essential

A gown is only as strong as its weakest point. Traditional stitched seams are full of holes, and ultrasonic seams can still fail under pressure.

Taped Seams are the gold standard for Level 4. This process applies a specialized, heat-sealed tape over every single seam, creating a 100% waterproof and virus-proof bond.

This technology ensures that seams are not a failure point, which is essential for passing ASTM F1671 and guaranteeing full-body protection against fluid ingress.

Material Analysis: 63gsm Heavy-Duty vs 36gsm Lightweight

IL-4063WKTP (63gsm, White) – Heavy-Duty Solution

Higher gram-weight provides superior durability, tear resistance, and is ideal for rigorous, high-abrasion tasks like decontamination and biohazard cleanup.

IL-4036YKTP (36gsm, Yellow) – Lightweight Solution

Provides the exact same Level 4 viral barrier but with enhanced comfort for long shifts in the ICU or ER.

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

The risks in an ICU are different from those in a decontamination zone. Our Level 4 solutions are purposefully designed to be the right tool for the job.

ICU/ER Nurses: For Unknown Risks and High Fluid Exposure

As the frontline, you face unknown pathogens and high-volume fluid exposure (trauma, intubation). You don’t have time to second-guess your PPE. Our Level 4 gowns (recommending the lightweight IL-4036YKTP) provide an immediate, absolute barrier. The ASTM F1671-rated fabric and taped seams mean you are protected from the moment you step in, allowing you to focus 100% on the patient, not on your PPE’s integrity.

Recommended: IL-4036YKTP (Lightweight)

Surgeons/OR Staff: Protecting the Sterile Field and the Team

While sterile surgical gowns are used in the field, Level 4 non-sterile gowns are critical for high-risk procedures (e.g., trauma, orthopedic) or for protecting staff during setup, cleaning, or when assisting. Their impervious barrier prevents patient-to-staff and staff-to-patient transmission of blood-borne pathogens, playing a vital role in preventing Surgical Site Infections (SSIs) and protecting the entire OR team from hazardous fluids.

Decontamination Staff: For Durability Against Chemical & Biological Hazards

Decontamination tasks involve prolonged exposure to the highest concentrations of biohazards and cleaning chemicals. This requires more than a barrier; it requires durability. Our heavy-duty 63gsm gown (IL-4063WKTP) is engineered for this. Its robust, tear-resistant microporous material and taped seams provide the most durable defense, ensuring integrity during rigorous cleaning and disinfection procedures.

Recommended: IL-4063WKTP (Heavy-Duty)

Biosafety Lab Researchers: Containment in BSL-3/4 Environments

In BSL-3 and BSL-4 labs, barrier integrity is synonymous with containment and safety. Any breach is catastrophic. An AAMI Level 4 gown that is ASTM F1671 compliant is an essential component of your PPE ensemble (e.g., with PAPRs). The fully taped seams and verified viral barrier of our gowns ensure total protection, providing the necessary confidence and safety for working with high-consequence pathogens.

Procurement Assurance & Compliance Hub

For Purchasing Managers & Value Analysis Committees. We provide the documentation, certifications, and supply chain transparency you need to simplify supplier vetting and de-risk your procurement.

FDA 510(k) Cleared & ISO 13485 Certified

Our AAMI Level 4 gowns are FDA 510(k) cleared Class II medical devices with verifiable clearance. We operate as an ISO 13485 certified manufacturer, proving our commitment to a medical-grade quality management system.

We provide all documentation (510(k) letter, SGS Test Reports) to fast-track your approval process and ensure you pass any internal or external audit with complete confidence.

Global Supply Chain Resilience & Stockpile-Ready

With manufacturing bases in Cambodia, we offer a diversified and resilient supply chain, mitigating geopolitical and logistic risks. Monthly capacity: 50,000+ pieces. 3-year shelf life.

Our products are ideal for your strategic stockpile programs. We offer bulk/contract pricing and work with you to ensure your critical supply is secured against future surges.

Available Documents for Download

Technical Specifications, Comparison & FAQ

All the technical details needed for a final decision.

Spec Sheet: IL-4063WKTP (63gsm) vs. IL-4036YKTP (36gsm)

Specification	IL-4063WKTP (Heavy-Duty)	IL-4036YKTP (Lightweight)
AAMI Rating	Level 4	Level 4
Material	PP+PE Microporous Laminate	PP+PE Microporous Laminate
Gram Weight	63gsm	36gsm
Color	White	Yellow
Seam Technology	100% Taped Seams	100% Taped Seams
Cuff Type	Knit Cuff	Knit Cuff
Closure	Tie-Neck & Waist	Tie-Neck & Waist
ASTM F1671 (Viral)	✓ Pass	✓ Pass
ASTM F1670 (Blood)	✓ Pass	✓ Pass
Recommended Use	Decontamination, High-Abrasion Tasks	ICU, ER, Long Shifts

Frequently Asked Questions

Are these gowns Sterile?

This series (IL-4036YKTP, IL-4063WKTP) is Non-Sterile. Their primary purpose is barrier protection for the wearer from external pathogens in high-risk (but not sterile) environments like the ICU, ER, or Decon. If your application requires a gown within a sterile field (e.g., in an OR) to prevent Surgical Site Infections, please refer to our separate Sterile Surgical Gown (SG) series, which are also available.

What is the correct Donning/Doffing procedure?

Correct procedure is as important as the gown itself. Doffing (removal) is the highest-risk moment for self-contamination. For a Level 4 gown, donning involves securing all ties and ensuring a good cuff-to-glove seal. Doffing must be done by rolling the gown ‘inside-out’ to contain contaminants, touching only the ‘clean’ inside. Always follow your facility’s infection control protocols or CDC guidelines. We can provide educational materials to support your staff training.

What is the shelf life and storage requirements?

Our Level 4 isolation gowns have a 3-year shelf life when stored properly. Store in a cool, dry place away from direct sunlight and extreme temperatures. Keep packaging intact until use to maintain product integrity. This extended shelf life makes our gowns ideal for strategic stockpile programs.

Can I get samples before bulk ordering?

Yes, we offer sample programs for qualified buyers including hospitals, healthcare facilities, and distributors. Contact our sales team to request product samples. Please provide your facility information and intended use case. We also offer on-site demonstrations for large healthcare systems.

Ready to Secure Your Level 4 Protection Supply?

Contact our B2B team for volume pricing, custom specifications, or OEM/ODM partnership opportunities.

50,000+

Monthly Production Capacity

30+

Years Manufacturing Experience

100%

FDA & ISO Compliant

AAMI Level 4 Isolation Gowns: ASTM F1671 Certified Viral Barrier Protection

Understanding AAMI Level 4 – The Non-Negotiable Standard for High-Risk Environments

AAMI Level 4 vs Level 3: The Critical Difference is the Viral Barrier

Fluid Splash Protection

Viral Barrier Protection

Decoding ASTM F1671: The Rigorous Viral Penetration Test

ASTM F1670: Resisting High-Pressure Blood Splashes

Our AAMI Level 4 Solutions: Engineering, Material & Clinical Design

100% Taped Seams

Microporous Laminate

Secure Knit Cuffs

Critical Technology: Why Taped Seams are Essential

Material Analysis: 63gsm Heavy-Duty vs 36gsm Lightweight

IL-4063WKTP (63gsm, White) – Heavy-Duty Solution

IL-4036YKTP (36gsm, Yellow) – Lightweight Solution

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

Procurement Assurance & Compliance Hub

FDA 510(k) Cleared & ISO 13485 Certified

Global Supply Chain Resilience & Stockpile-Ready

Available Documents for Download

Technical Specifications, Comparison & FAQ

Spec Sheet: IL-4063WKTP (63gsm) vs. IL-4036YKTP (36gsm)

Frequently Asked Questions

Are these gowns Sterile?

What is the correct Donning/Doffing procedure?

What is the shelf life and storage requirements?

Can I get samples before bulk ordering?

Ready to Secure Your Level 4 Protection Supply?

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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