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 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.
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.
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.
Model: IL-0023BTU
Specifically designed based on clinical feedback for high-performance barrier protection and user-centric features that address common clinical frustrations.
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.
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.
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.
Different healthcare roles face unique challenges. See how AAMI Level 3 gowns address specific protection needs across various high-risk clinical settings.
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.
Supply Chain Instability & Budget Constraints
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).
Verifying ‘Impervious’ Claims
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.
High-Speed, Unpredictable Fluid Exposure
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.
Risk of Blood Soak-Through
You work in the ‘decon’ area, manually cleaning heavily soiled instruments. You are constantly exposed to splashes of contaminated water, blood, and cleaning chemicals.
Constant Splashes During Decontamination
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.
Finding a Reliable Manufacturing Partner
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.
Eliminate distributor markups with transparent manufacturer-direct pricing. Our global manufacturing footprint enables rapid scaling for large-volume GPO contracts and government tenders.
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.
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.
Private Label Services
OEM Manufacturing
Technical Documentation
Take the next step to partner with a trusted global PPE manufacturer. Our expert team is ready to assist with your procurement needs.
Planning a large-volume purchase for your hospital network, GPO, or distribution center? Get competitive wholesale pricing.
Need to verify specifications for your Value Analysis Committee? Get complete TDS with test results.
Have questions about AAMI levels, material differences, or logistics? Get expert consultation.
30+
Years Experience
ISO 13485
Certified
FDA
Registered
Global
Manufacturing
© 2025 Medtecs Group. All rights reserved.|AAMI Level 3 Isolation Gown Manufacturer|ISO 13485 Certified
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