Manufacturer Direct

FDA Registered

ISO 13485 Certified

AAMI Level 3 Isolation Gown Manufacturer

Premium PE Coated Protection for Moderate-Risk Clinical Environments

As a prime manufacturer and B2B partner, Medtecs delivers fully compliant AAMI Level 3 isolation gowns (Model: IL-0023BTU) engineered for fluid-intensive tasks. Secure your hospital network’s supply chain with a trusted, vertically integrated partner committed to quality.

ASTM F1670 Compliant

AATCC 127 Tested

Impervious Barrier

Compliance & Standards

Decoding AAMI PB70 Level 3 & Our Compliance Commitment

Trust is built on verifiable compliance. For procurement managers and infection control specialists, understanding the specifics of AAMI Level 3 is critical for protecting staff.

We detail what Level 3 testing entails (AATCC 42 & AATCC 127) and how our gowns are rigorously tested to meet these stringent requirements for reliable barrier protection against blood, fluids, and other potentially infectious materials (OPIM).

AAMI Level 3

ASTM F1670

FDA Registered

ISO 13485

What Defines AAMI Level 3 Protection vs. Level 2?

AAMI Level 2 gowns only pass AATCC 42 water impact test. Level 3 gowns must pass both AATCC 42 *and* AATCC 127 hydrostatic pressure test. This proves reliable barrier against pressurized fluids, making the gown effectively waterproof.

Hydrostatic Pressure Tested

The Critical Role of ASTM F1670

While AAMI PB70 tests for water resistance, ASTM F1670 validates resistance to synthetic blood penetration. This pass/fail test proves the material can block blood-borne pathogens under contact.

Blood-Borne Pathogen Resistance

Our Manufacturing Credentials: FDA, ISO 9001, ISO 13485 & cGMP

Medtecs is a cGMP-compliant, ISO 9001 and ISO 13485 certified manufacturer. Our products are registered with the FDA as Class I medical devices. We provide all necessary documentation—including Technical Data Sheets, Declarations of Conformity, and test reports—to satisfy your hospital’s accreditation and procurement audits.

Medtecs PE Coated Level 3 Gown

Model: IL-0023BTU

Specifically designed based on clinical feedback for high-performance barrier protection and user-centric features that address common clinical frustrations.

The Impervious Barrier: PE Coated Fabric

Polyethylene Coated fabric creates a non-porous, impervious plastic film bonded to durable non-woven polypropylene. This material creates an absolute barrier against fluids, far exceeding splash resistance of standard SMS.

Solving the #1 Gown Failure: Thumb Loop Solution

Integrated thumb loops anchor sleeves securely under gloves, eliminating the exposed wrist gap from ‘sleeve ride-up.’ This ensures total, gap-free interface and 360-degree protection during critical procedures.

Design for Clinical Efficiency: Overhead Donning

Overhead ‘apron-style’ design enables rapid, intuitive donning. Combined with secure waist ties and full-back coverage, it ensures complete frontal and back protection without compromising speed.

Key Specifications

•Material: PE Coated Non-Woven Polypropylene

•Protection Level: AAMI Level 3

•Closure: Overhead Donning with Waist Ties

•Cuffs: Knit Cuffs with Thumb Loops

•Coverage: Full Front and Back

Compliance & Testing

✓AATCC 42: Water Impact Penetration

✓AATCC 127: Hydrostatic Pressure Resistance

✓ASTM F1670: Synthetic Blood Penetration

✓FDA: Class I Medical Device

✓ISO 13485: Quality Management Certified

Application Scenarios

Level 3 Protection for Your Specific Environment

Different healthcare roles face unique challenges. See how AAMI Level 3 gowns address specific protection needs across various high-risk clinical settings.

Hospital Procurement Manager

Supply Chain Instability & Budget Constraints

You must source compliant AAMI Level 3 gowns at a predictable cost, but market volatility and unreliable suppliers create stockout risks and budget overruns. You need a stable, long-term partner.

Our Solution:Medtecs Manufacturer-Direct Partnership: Transparent pricing and resilient global supply chain

Supply Chain Instability & Budget Constraints

Infection Control Specialist

Verifying ‘Impervious’ Claims

Your goal is preventing HAIs. You know that not all ‘Level 3’ gowns are equal. You must validate that the gown is truly impervious to fluids under pressure (AATCC 127) and resists blood (ASTM F1670).

Our Solution:PE-Coated Gown (IL-0023BTU): Full test reports for AATCC 127 and ASTM F1670

Verifying ‘Impervious’ Claims

Emergency Room (ER) Nurse

High-Speed, Unpredictable Fluid Exposure

In a trauma situation, you face high-velocity splashes and fluid exposure. You need a gown that is fast to don, impervious, and won’t ride up, leaving your wrists exposed.

Our Solution:IL-0023BTU with Thumb Loops: Overhead design and secure sleeve anchoring

High-Speed, Unpredictable Fluid Exposure

ICU Nurse / Phlebotomist

Risk of Blood Soak-Through

Tasks like drawing blood from an arterial line or managing incontinent patients create conditions where fluid can soak through a standard SMS gown over time. You need a barrier you can trust.

Our Solution:ASTM F1670 Compliant Barrier: Non-porous protection from blood-borne pathogens

Risk of Blood Soak-Through

Sterile Processing (SPD) Staff

Constant Splashes During Decontamination

You work in the ‘decon’ area, manually cleaning heavily soiled instruments. You are constantly exposed to splashes of contaminated water, blood, and cleaning chemicals.

Our Solution:Full Coverage Impervious Gown: Reliable barrier against biohazardous fluids

Constant Splashes During Decontamination

Medical Equipment Distributor

Finding a Reliable Manufacturing Partner

Your hospital clients demand compliant products and a stable supply. You need a manufacturing partner—not a competitor—who can offer quality products, competitive pricing, and even OEM/private label capabilities.

Our Solution:Medtecs Distributor Program: OEM/ODM services with technical documentation

Finding a Reliable Manufacturing Partner

Supply Chain Excellence

The Medtecs Supply Chain Advantage

In a volatile post-pandemic market, supply chain stability is non-negotiable for healthcare. As a vertically integrated manufacturer with over 30 years of experience, Medtecs offers unmatched reliability, end-to-end quality control, and scalable capacity.

Manufacturer-Direct Pricing & Scalability

Eliminate distributor markups with transparent manufacturer-direct pricing. Our global manufacturing footprint enables rapid scaling for large-volume GPO contracts and government tenders.

Vertical Integration = Auditable Quality

We manage the entire process from raw materials to finished goods. This ‘Group-to-Hospital’ vertical integration gives total control over quality with an auditable, transparent supply chain.

Full Traceability: Raw Material to Finished Gown

Control the entire production line from PE resin and polypropylene to final gown. This means auditable quality, consistent product, and transparent supply chain that distributors cannot offer.

Partner with Medtecs: Distributor & Wholesaler Program

Are you a medical equipment distributor or wholesaler? We provide a dedicated B2B program with OEM and private label services for our compliant AAMI Level 3 gowns. Build your brand with our manufacturing power.

Private Label Services

OEM Manufacturing

Technical Documentation

Secure Your AAMI Level 3 Gown Supply Today

Take the next step to partner with a trusted global PPE manufacturer. Our expert team is ready to assist with your procurement needs.

Request Bulk Quotation

Planning a large-volume purchase for your hospital network, GPO, or distribution center? Get competitive wholesale pricing.

Download Technical Data

Need to verify specifications for your Value Analysis Committee? Get complete TDS with test results.

Speak with Specialist

Have questions about AAMI levels, material differences, or logistics? Get expert consultation.

30+

Years Experience

ISO 13485

Certified

FDA

Registered

Global

Manufacturing

AAMI Level 3 Isolation Gown Manufacturer

Decoding AAMI PB70 Level 3 & Our Compliance Commitment

What Defines AAMI Level 3 Protection vs. Level 2?

The Critical Role of ASTM F1670

Our Manufacturing Credentials: FDA, ISO 9001, ISO 13485 & cGMP

Medtecs PE Coated Level 3 Gown

The Impervious Barrier: PE Coated Fabric

Solving the #1 Gown Failure: Thumb Loop Solution

Design for Clinical Efficiency: Overhead Donning

Key Specifications

Compliance & Testing

Level 3 Protection for Your Specific Environment

Hospital Procurement Manager

Supply Chain Instability & Budget Constraints

Infection Control Specialist

Verifying ‘Impervious’ Claims

Emergency Room (ER) Nurse

High-Speed, Unpredictable Fluid Exposure

ICU Nurse / Phlebotomist

Risk of Blood Soak-Through

Sterile Processing (SPD) Staff

Constant Splashes During Decontamination

Medical Equipment Distributor

Finding a Reliable Manufacturing Partner

The Medtecs Supply Chain Advantage

Manufacturer-Direct Pricing & Scalability

Vertical Integration = Auditable Quality

Full Traceability: Raw Material to Finished Gown

Partner with Medtecs: Distributor & Wholesaler Program

Secure Your AAMI Level 3 Gown Supply Today

Request Bulk Quotation

Download Technical Data

Speak with Specialist

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,

BY Solution :

Trauma Surgeons,

Triage Nurses,

ICU Staff,

Pharmacy,

Nursing,

EVS,

Technicians,

Compliance Officers,

OHS Personnel,

Contact Us

Catalog Download

我們使用 Cookies 分析技術以提升您的使用者體驗。

Thank You for Contacting Medtecs