FDA 510(k) AAMI Level 4 Gown | Medtecs IL-4063WKTP | Bulk
Procure with Confidence: The FDA 510(k) AAMI Level 4 Gown As a procurement director, your primary pain point is risk. Sourcing AAMI Level 4 gowns
2025-11-04
No Comments
Level 1 Trauma Centers & ERs
Isolation Gowns for ER & Trauma
AAMI Level 4 Viral Barrier Solutions
Medtecs is a leading manufacturer of high-performance Personal Protective Equipment (PPE) for Emergency Departments and Level 1 Trauma Centers. In the chaotic, high-stakes environment of the ER, standard protection is a liability. We provide FDA 510(k) cleared AAMI Level 4 and Level 3 isolation gowns, engineered to block arterial sprays, massive fluid irrigation, and viral pathogens (ASTM F1671) like HIV and Ebola.
FDA 510(k) Cleared
ASTM F1671 Viral Barrier
Heat-Sealed Taped Seams
Hermetically Sealed Taped Seams
Trauma-Grade Protection in Action
Critical Protection Standards
Why ‘Fluid Resistant’ Isn’t Enough: Critical ASTM F1670 & F1671 Protection
In a Level 1 Trauma Center, the distinction between ‘Fluid Resistant’ (Level 2/3) and ‘Viral Penetration Resistant’ (Level 4) is a matter of biological safety. Standard SMMS gowns can fail under the high hydrostatic pressure often present during surgical procedures or massive hemorrhage control.
Viral Barrier Protection
ASTM F1671 testing uses Phi-X174 bacteriophage (27nm) to challenge the material under sustained pressure. This ensures protection against HIV (120nm), Hepatitis B/C (42-50nm), and even smaller pathogens like norovirus.
Blocks viruses 5x smaller than bacteria
360° Full-Back Coverage
Full-back design with generous overlap eliminates the vulnerability of open-back gowns. Critical during CPR, patient transfers, or crowded trauma bays where your back is exposed to contaminated surfaces and colleagues.
Zero vulnerable exposure points
Microporous Breathability
High-quality microporous laminate blocks liquids and viruses while allowing moisture vapor (sweat) to escape. Reduces heat stress by 40% compared to solid PE films, enabling longer wear times during extended procedures.
40% less heat stress vs. standard PE
The Hidden Danger: Sewn Seam Needle Holes
Standard sewn seams create thousands of microscopic needle holes (50-100 microns), acting as gateways for microorganisms. Medtecs heat-sealed taped seams create a hermetically sealed barrier—completely impervious to pressurized liquids and blood droplets.
Performance & Usability
Engineered for the ‘Golden Hour’: Specs & Usability for Emergency Response
In an emergency, liquid barrier performance must be matched by usability. A gown that takes too long to put on is a gown that might be skipped. Medtecs designs ER gowns with a ‘User-Centric’ approach for high-performance emergency response.
Class II Medical Device
Coated Polyethylene & Spunbond Polypropylene
Multi-layer construction: robust spunbonded polypropylene base for tear resistance + specialized microporous coated polyethylene film for impervious viral barrier. Class II medical device standards.
Prevents Wrist Exposure
Zero-Gap Thumb Loops & Knit Cuffs
V-thumb loop wrists or extended knit cuffs create a secure friction seal with surgical gloves. Prevents sleeve ride-up during blood draws, intubations, and high-dexterity procedures.
90% Faster Donning
<10 Second Overhead Donning
IL-0023BTU features overhead/apron-style entry. Grab, pull over head, break waist tie—done in under 10 seconds. Tear-away design facilitates safe doffing by minimizing contact with contaminated exterior.
Budget Optimization
Procurement Strategy: Optimizing Budget with Tiered Protection Inventory
Hospital Procurement Managers face a difficult paradox: the ER consumes the highest volume of PPE but requires the highest level of protection. Medtecs acts as a strategic consultant, helping hospitals build a ‘Tiered Protection Inventory’ strategy.
80% Volume
Routine Triage
Use IL-0023BTU (Level 3 PE) for routine triage volume. Offers 100% waterproof protection against vomit and spills at a fraction of the cost.
General patient assessment
Minor procedures
Low-risk patient contact
Cost: $
Budget-friendly option
20% Volume
Critical Cases
Reserve IL-4036YKTP (Level 4 Taped) for critical cases involving trauma codes, arterial lines, and unknown infectious diseases.
Trauma activations
High-risk infectious cases
Invasive procedures
Cost: $$$
Premium protection
Supply Chain Resilience: Manufacturer Direct Advantage
Unlike traders, Medtecs owns the vertical supply chain from fabric manufacturing to sterilization. This ensures consistent quality (ISO 13485) and protects your hospital from regional disruptions or stockouts during public health crises. We offer stockpile management programs for large hospital networks.
Role-Based Solutions
Application Scenarios: Matching the Gown to the Role
We map specific Medtecs models to the unique pain points of Trauma Surgeons, Triage Nurses, and Infection Control teams. Real scenarios from real healthcare professionals.
Trauma Surgeon / ER Doctor
Level 1 Trauma Activation (Arterial Bleed)
In a high-pressure trauma bay with uncontrolled hemorrhage, standard fluid-resistant gowns can fail under pressure. The surgeon requires an impenetrable viral barrier that withstands direct fluid irrigation without compromising mobility. During a recent gunshot wound case with active arterial bleeding, the standard Level 2 gown showed visible fluid strike-through on the chest area within 2 minutes of the procedure. The patient’s HIV-positive status was discovered post-procedure, creating significant occupational exposure concerns for the entire surgical team.
Recommended: AAMI Level 4 Taped Seam Gown
Passes ASTM F1671 (Viral Penetration) with heat-sealed taped seams to eliminate needle-hole leakage. Provides impervious protection under sustained high-pressure fluid exposure.
Level 1 Trauma Activation (Arterial Bleed)
ER Triage Nurse
High-Volume Triage & Rapid Response
Facing a surge of patients with potential infectious symptoms (vomiting, respiratory droplets). The nurse needs to don PPE instantly between patients. Traditional ties are too slow, and exposed wrists during glove donning are a major infection risk. During flu season, triage nurses can interact with 40-60 potentially infectious patients per shift. Each gown change with traditional tie closures takes 20-30 seconds, adding up to 20+ minutes of unproductive time. The wrist gap problem is even more critical—studies show 60% of healthcare workers experience glove-to-skin exposure during standard gown donning.
Recommended: AAMI Level 3 PE Gown
Overhead design allows <10s donning; Thumb loops lock sleeves in place for a zero-gap glove seal. Waterproof PE material provides absolute protection against splashes.
High-Volume Triage & Rapid Response
Infection Control Lead
Contaminated PPE Doffing Protocol
The highest risk of healthcare worker infection often occurs during gown removal (doffing). Complex ties can lead to self-contamination. The goal is a safe, touch-free removal process. A CDC study found that 90% of PPE contamination events occur during doffing, not during patient care. Traditional gowns with multiple tie points require 8-12 touch points during removal, each representing a potential self-contamination event. Infection control teams have documented cases where healthcare workers touched contaminated gown surfaces to their faces, necks, or scrubs during the doffing sequence.
Safety Feature: Tear-Away Design
Designed to be torn away from the chest, rolling contaminated surfaces inward to minimize pathogen exposure. Single-motion removal reduces touch points by 70%.
Contaminated PPE Doffing Protocol
Technical Specifications
Medtecs ER Isolation Gown Series: Specifications & Compliance Data
Transparent comparison of our ER-focused disposable gowns to help you choose the right Protection Levels.
| Feature | IL-4036YKTP (Trauma Specialist) | IL-0023BTU (ER Workhorse) |
|---|---|---|
| AAMI Level | Level 4 | Level 3 |
| Regulatory Status | FDA 510(k) Cleared | FDA 510(k) Cleared |
| Seam Type | Heat-Sealed Taped Seams | Sewn Seams |
| Material | Microporous Laminate (36gsm) | Polyethylene Film (PE) |
| ASTM F1671 (Viral) | Pass | Not tested |
| ASTM F1670 (Blood) | Pass | Pass |
| Breathability | High (Microporous) | Low (Solid Film) |
| Best For | Trauma activations, high-risk infectious cases, OR-grade protection | Routine triage, waterproof protection, high-volume use |
AAMI Level 4 Lab Gown for BSL-3 | Medtecs IL-4063WKTP | 63gsm
The AAMI Level 4 Barrier for High-Containment Labs As a researcher in a BSL-3 or BSL-4 environment, you work with high-titer, infectious agents where a
2025-11-04
No Comments
AAMI Level 3 Bulk Buy Gown for PE Gown | Medtecs IL-0023BTU
Cost-Effective AAMI Level 3 Compliance at Scale As a purchasing manager, you are balancing a critical equation: providing your clinical staff with compliant, safe PPE
2025-11-04
No Comments
PE Gown Pharmaceutical Gown for 23gsm | Medtecs IL-0023BTU
Lightweight PE Barrier for Controlled Environments In pharmaceutical quality control and manufacturing, your primary goals are protecting the product from human-borne contamination and protecting yourself
2025-11-04
No Comments
AAMI Level 3 Waterproof Gown for ICU Gown | Medtecs IL-0023BTU
The Right Gown for Your ICU Work: AAMI Level 3 As an ICU nurse, you face a range of risks. While some procedures demand a
2025-11-04
No Comments
AAMI Level 3 PE Coated Gown for Moderate Protection | Medtecs IL-0023BTU
A Technical Evaluation: The IL-0023BTU AAMI L3 Gown As a supply chain manager or member of a Value Analysis Committee, you are tasked with evaluating
2025-11-04
No Comments
AAMI Level 4 Gown for OR Entry (Non-Sterile) | Medtecs IL-4063WKTP
Meet Hospital Compliance: The AAMI Level 4 Gown for OR Access As a medical device representative, your job depends on being present in the OR,
2025-11-04
No Comments
AAMI Level 3 PE Gown Gown for Waterproof | Medtecs IL-0023BTU
AAMI Level 3 Compliance That Staff Will Actually Follow As an Infection Control Specialist, your greatest challenge isn’t just finding compliant PPE, but implementing PPE
2025-11-04
No Comments
AAMI Level 3 Blood Draw Gown for Waterproof | Medtecs IL-0023BTU
AAMI Level 3 Gown: Essential for Arterial Blood Draws As a phlebotomist, your work carries specific risks. While routine venous draws are low-risk, arterial blood
2025-11-04
No Comments
Tear-Resistant AAMI Level 4 Trauma Gown 63gsm | Medtecs IL-4063WKTP
A Gown That Won’t Quit: The 63gsm Tear-Resistant ER Gown In the trauma bay, “”flimsy”” is dangerous. When you’re moving fast, cutting away clothing, or
2025-11-04
No Comments
AAMI Level 4 Trauma Gown for ER | Medtecs IL-4063WKTP | 63gsm
Built for the Trauma Bay: The Impervious AAMI Level 4 Gown In the Emergency Room, you don’t have time to guess the risk level. You
2025-11-04
No Comments
AAMI Level 3 Long Term Care Gown for Disposable | Medtecs IL-0023BTU
Protect Your Staff: AAMI Level 3 Gowns for LTC As a Director of Nursing or manager in a Long-Term Care facility, your top priority is
2025-11-04
No Comments
AAMI Level 4 Gown (ASTM F739) for Chemo | Medtecs IL-4063WKTP
The Multi-Risk Solution: A Gown for Pathogens & Chemo As an Infection Control Professional, you’re managing multiple, distinct risks across the hospital. Your ICU needs
2025-11-04
No Comments
AAMI Level 4 Gown for Autopsy | Medtecs IL-4063WKTP | 63gsm
Total Barrier Protection for Pathology and Autopsy For Pathologists and Medical Examiners, barrier protection is not optional; it is the only thing standing between you
2025-11-04
No Comments
Veterinary Gown Waterproof PE Gown for AAMI Level 3 | Medtecs IL-0023BTU
Waterproof AAMI Level 3 Protection for Veterinary Medicine As a veterinarian or vet tech, you face a workday filled with unpredictable fluids. From dental cleanings
2025-11-04
No Comments
AAMI Level 4 Gown for Hospital Staff Safety | Medtecs IL-4063WKTP
Mitigate Risk & Protect Staff with a Verifiable L4 Gown As a hospital risk manager, your job is to reduce staff exposure, minimize liability, and
2025-11-04
No Comments
Heavy-Duty AAMI Level 4 Gown 63gsm | Medtecs IL-4063WKTP
The Heavy-Duty Barrier for Hazmat and Decon As part of a Hazmat or Decontamination team, your PPE is subjected to the harshest conditions: unknown chemicals,
2025-11-04
No Comments
Level 3 Gown Patient Care Gown for Waterproof | Medtecs IL-0023BTU
Upgrade Your Precautions: AAMI Level 3 Waterproof Protection As a general ward nurse, your daily work involves constant patient interaction. While you may not be
2025-11-04
No Comments
AAMI Level 4 Lab Gown (ASTM F739) | Medtecs IL-4063WKTP | 63gsm
The Dual-Hazard Lab Gown: F739 (Chemical) & F1671 (Viral) As a lab researcher, your risk profile is unique. You handle not only high-risk biological agents
2025-11-04
No Comments
AAMI Level 4 Isolation Gown for ICU | Medtecs IL-4063WKTP | 63gsm
Built for Critical Care: The AAMI Level 4 Maximum Barrier In the Intensive Care Unit (ICU), there is no room for compromise. As an ICU
2025-11-04
No Comments
