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.
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.
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.
Every detail is engineered to eliminate failure points and ensure absolute barrier integrity during critical procedures.
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.
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.
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.
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.
Higher gram-weight provides superior durability, tear resistance, and is ideal for rigorous, high-abrasion tasks like decontamination and biohazard cleanup.
Provides the exact same Level 4 viral barrier but with enhanced comfort for long shifts in the ICU or ER.
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.
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.
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 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.
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.
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.
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.
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.
All the technical details needed for a final decision.
| 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 |
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.
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.
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.
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.
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