FDA 510(k) Cleared

AAMI Level 4

ASTM F1671 Certified

FDA 510(k) Cleared Isolation Gowns Manufacturer

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.

100% Heat-Sealed Taped Seams – Zero-Leak Protection

Heavy-Duty 63gsm Fabric – Tear & Puncture Resistant

ANSI/AAMI PB70-2012 Compliant – Highest Protection Level

ISO 13485 Certified

ISO 9001 Certified

Engineered for Your Specific Clinical Environment

Different healthcare professionals face different risks. Our FDA-cleared configurations are designed to match specific protection needs.

Hospital Procurement Director

Mitigating Regulatory Liability

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.

Recommended: IL-4063WKTP (510k Cleared)

Trauma Surgeon / ER Team

The ‘Armor’ for Chaotic Trauma Bays

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.

Recommended: IL-4063WKTP (Heavy-Duty)

ICU Nurse / Infection Control

Visual Shield for High-Risk Isolation

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.

Recommended: IL-4036YKTP (High-Vis Yellow)

Oncology Nurse

Dual Protection: Chemo & Biohazards

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.

Recommended: IL-4063WKTP (Chemo Rated)

Regulatory Compliance

Why FDA 510(k) Clearance is Non-Negotiable

For Hospital Procurement Directors and Risk Managers, sourcing AAMI Level 4 isolation gowns without a valid 510(k) clearance is a critical liability.

CFR Title 21 Regulated

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.

Legally Marketed Device

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.

Premarket Notification

Unlike lower-level gowns, a simple self-declaration is insufficient. Our 510(k) premarket notification ensures full compliance.

Transparency Guide

Verify our compliance yourself

1 Access FDA Database

2 Enter 510(k) Number

3 Verify Classification

ANSI/AAMI PB70-2012

The Science of Imperviousness

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.

Waterproof Composite

PP + PE Barrier Technology

High-density Polypropylene (PP) spunbond substrate laminated with Polyethylene (PE) breathable film creates an impervious shield.

Zero Needle Holes

100% Heat-Sealed Taped Seams

Standard stitched seams create needle holes. Our taped seams physically seal every seam, creating a monolithic zero-leak surface.

Viral Protection

ASTM F1671 Viral Barrier

Certified resistance against bloodborne pathogens and viral penetration. While Level 3 stops liquids, Level 4 stops viruses.

Extended Wear Ready

Breathable Comfort Technology

Our PE breathable film balances impervious protection with thermal comfort, reducing heat stress during extended wear in isolation units.

White | 63gsm

IL-4063WKTP

Ideal for

Trauma & Oncology

Heavy-duty 63gsm fabric weight

Exceptional tear & puncture resistance

ASTM F739-12 chemo drug resistance

Non-sterile utility grade

Yellow | 36gsm

IL-4036YKTP

Ideal for

ICU & Isolation

High-visibility yellow color

Breathable 36gsm PE film

Instant 'Contact Precautions' signal

Reduced heat stress design

Global Manufacturer

Supply Chain Resilience

Procurement Managers need reliability. As a vertically integrated manufacturer, Medtecs Corp. owns the entire production line, ensuring consistent quality and supply.

ISO 13485 & ISO 9001

Manufactured in facilities certified to international quality standards.

Vertically Integrated

We own the entire production line, ensuring consistent quality and supply.

Bulk Efficiency

Available in Pack of 10, with 100 pcs/case to optimize warehouse density.

Pandemic Ready

FDA 510(k) clearance makes these gowns ideal for national stockpiles.

Validating Medtecs as a primary supplier aids in protecting your hospital from supply chain disruptions.

FDA 510(k) Cleared Isolation Gowns Manufacturer

Engineered for Your Specific Clinical Environment

Hospital Procurement Director

Mitigating Regulatory Liability

Trauma Surgeon / ER Team

The ‘Armor’ for Chaotic Trauma Bays

ICU Nurse / Infection Control

Visual Shield for High-Risk Isolation

Oncology Nurse

Dual Protection: Chemo & Biohazards

Why 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

The Science of Imperviousness

PP + PE Barrier Technology

100% Heat-Sealed Taped Seams

ASTM F1671 Viral Barrier

Breathable Comfort Technology

IL-4063WKTP

IL-4036YKTP

Supply Chain Resilience

ISO 13485 & ISO 9001

Vertically Integrated

Bulk Efficiency

Pandemic Ready

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,

Tie Neck Isolation Gowns,

BY Compliance Standard Isolation Gowns:

FDA 510(k) Cleared Isolation Gowns,

ASTM F1670 Compliant Isolation Gowns (Synthetic Blood),

BY Fabric Weight (GSM) Isolation Gowns:

25 gsm Isolation Gowns,

36 gsm Isolation Gowns,

BY Back Style Isolation Gowns:

Open Back Isolation Gowns,

BY Material Isolation Gowns:

SMS Isolation Gowns,

PE Coated Isolation Gowns,

BY Usability Isolation Gowns:

BY Seam Style Isolation Gowns:

BY Application / Use Case Isolation Gowns:

Isolation Gowns for ICU(Intensive Care Unit),

Isolation Gowns for ER (Emergency Room) & Trauma,

Isolation Gowns for Decontamination,

Isolation Gowns for Basic Patient Care & Visitor Use,

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