Secure your hospital’s supply chain with FDA 510(k) cleared, fully taped seams isolation gowns. Certified viral barrier protection for ICU, Trauma, and Infectious Disease units. Featured Product Medtecs IL-4063WKTP Different healthcare professionals face different risks. Our FDA-cleared configurations are designed to match specific protection needs. Sourcing AAMI Level 4 gowns without valid FDA 510(k) clearance is a critical liability risk. Medtecs gowns are legally marketed Class II devices with verifiable 510(k) premarket notification, ensuring your facility meets all federal compliance requirements for high-risk PPE. In a chaotic trauma bay, gowns snag and tear. The IL-4063WKTP features heavy-duty 63gsm fabric with exceptional tear and puncture resistance. Combined with taped seams, it provides an impervious barrier against high-pressure arterial sprays and heavy fluid exposure. For long shifts in isolation units, visual compliance is key. The IL-4036YKTP’s high-visibility yellow color signals ‘Contact Precautions’ instantly. Its breathable 36gsm PE film balances 100% fluid-proof protection with thermal comfort, reducing fatigue during extended wear. Oncology staff fear hazardous drug permeation. The IL-4063WKTP is not only a viral barrier but is also compliant with ASTM F739-12 for chemotherapy drug resistance. It offers a comprehensive shield against both infectious agents and chemical toxicity. For Hospital Procurement Directors and Risk Managers, sourcing AAMI Level 4 isolation gowns without a valid 510(k) clearance is a critical liability. The FDA regulates non-sterile Level 4 gowns under CFR Title 21 as Surgical Apparel (Product Code: FYC). This Device Class II designation mandates rigorous review. By choosing Medtecs, you verify your regulatory status with a legally marketed device backed by a designated US FDA Agent and a comprehensive Control Plan. Unlike lower-level gowns, a simple self-declaration is insufficient. Our 510(k) premarket notification ensures full compliance. Verify our compliance yourself For Infection Control Specialists, the distinction between protection levels is critical. Our gowns are engineered to meet strict test requirements set forth by ANSI/AAMI PB70-2012. High-density Polypropylene (PP) spunbond substrate laminated with Polyethylene (PE) breathable film creates an impervious shield. Standard stitched seams create needle holes. Our taped seams physically seal every seam, creating a monolithic zero-leak surface. Certified resistance against bloodborne pathogens and viral penetration. While Level 3 stops liquids, Level 4 stops viruses. Our PE breathable film balances impervious protection with thermal comfort, reducing heat stress during extended wear in isolation units. Ideal for Trauma & Oncology Ideal for ICU & Isolation Procurement Managers need reliability. As a vertically integrated manufacturer, Medtecs Corp. owns the entire production line, ensuring consistent quality and supply. Manufactured in facilities certified to international quality standards. We own the entire production line, ensuring consistent quality and supply. Available in Pack of 10, with 100 pcs/case to optimize warehouse density. FDA 510(k) clearance makes these gowns ideal for national stockpiles.
FDA 510(k) ClearedAAMI Level 4ASTM F1671 Certified
FDA 510(k) Cleared Isolation Gowns Manufacturer
ISO 13485 Certified ISO 9001 Certified
Heavy-Duty 63gsm
Role-Based ProtectionEngineered for Your Specific Clinical Environment
Hospital Procurement Director
Mitigating Regulatory Liability
Recommended: IL-4063WKTP (510k Cleared)
Trauma Surgeon / ER Team
The ‘Armor’ for Chaotic Trauma Bays
Recommended: IL-4063WKTP (Heavy-Duty)
ICU Nurse / Infection Control
Visual Shield for High-Risk Isolation
Recommended: IL-4036YKTP (High-Vis Yellow)
Oncology Nurse
Dual Protection: Chemo & Biohazards
Recommended: IL-4063WKTP (Chemo Rated)
Regulatory ComplianceWhy FDA 510(k) Clearance is Non-Negotiable
CFR Title 21 Regulated
Legally Marketed Device
Premarket Notification
Transparency Guide
1
Access FDA Database
2
Enter 510(k) Number
3
Verify Classification
ANSI/AAMI PB70-2012The Science of Imperviousness
Waterproof CompositePP + PE Barrier Technology
Zero Needle Holes100% Heat-Sealed Taped Seams
Viral ProtectionASTM F1671 Viral Barrier
Extended Wear ReadyBreathable Comfort Technology
White | 63gsmIL-4063WKTP
Yellow | 36gsmIL-4036YKTP
Global ManufacturerSupply Chain Resilience
ISO 13485 & ISO 9001
Vertically Integrated
Bulk Efficiency
Pandemic Ready
Validating Medtecs as a primary supplier aids in protecting your hospital from supply chain disruptions.
Dual Protection for Oncology: Hazardous Drugs & Pathogens As an oncology nurse, you face a unique dual risk: exposure to hazardous chemotherapy drugs and protecting
A Gown That Lasts Your Entire Shift: The 63gsm L4 Gown As an ICU nurse, your 12-hour shift is a marathon. You are constantly moving,
Taped Seams: The Impervious Seal for Autopsy As a pathologist or medical examiner, your work involves guaranteed, prolonged exposure to high volumes of blood and
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,
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
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
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
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,
The Compliant Solution for AAMI Level 4 Protection As an Infection Control Professional, your primary concern is staff safety and hospital-wide compliance. Sourcing AAMI Level
Taped Seams: Your 100% Seal Against Hazardous Drugs As an oncology nurse, you know that a gown is only as strong as its weakest point.
Built for Critical Care: The ICU’s AAMI Level 4 Barrier In the Intensive Care Unit, you need absolute confidence in your PPE. The Medtecs IL-4036YKTP
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
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
The Frontline Defense for Infectious Disease Units As a frontline healthcare worker in an infectious disease unit, you are the barrier. When dealing with novel
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
AAMI Level 4 Protection for Non-Sterile OR Staff As a member of the surgical team—such as an anesthesiologist, circulator, or device representative—you are not part
The Strategic-Buy: A Durable, Compliant AAMI L4 Gown As a procurement or supply chain manager, your goal is to source compliant, high-quality products that meet
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
Mitigate Risk & Protect Staff with a Verifiable L4 Gown As a hospital risk manager, your job is to reduce staff exposure, minimize liability, and
The Reliable AAMI L4 Gown That Ends Clinician Complaints As a supply chain manager, you’re caught between procurement (cost) and clinicians (quality). Your #1 complaint
A short description that introduces visitors to your portfolio.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
© 2025 All Rights Reserved.
