AAMI Level 4 Gown, Approved List, FDA

FDA Registered & Compliant Level 4 Gown

FDA Registered: Manufactured by Medtecs, an FDA-registered establishment.
AAMI Level 4: Meets highest standards for fluid/viral barrier.
ISO 13485 Certified: Ensures quality management systems.
Taped Seams: Fully sealed for maximum compliance and protection.

Approved / Certified Gown Attributes

Product Attribute	Details
Product name	yellow fda registered non-surgical disposable gown
Product Type	Disposable Isolation Gowns (w/ seal tape)
Model Number	IL-4036YKTP
Brand Name	Medtecs Personal Protective Equipment
Material	PPSB laminated w/ breathable PE film
Color	Yellow
Size	free size
Feature	FDA Registered, ISO 13485, AAMI Level 4, Taped Seams, Disposable
Function	Personal Protective Equipment
Application	Hospital, Medical Procurement, Government, Distributor
Applicable People	Adult
Disinfecting Type	none
Instrument classification	Class I
Safety standard	EN14683, ASTM
Filter Rating	SGS, AAMI Level 4 Testing Report (Gown)
Quality Certification / Certifications	Cambodia
Place of Origin	Yes
Stock	None
Shelf Life	3 Years
MOQ	50,000 pieces
Supply Ability	50,000 pieces per Month
Keyword	Medical Polymer Materials & Products
Product Properties	X

Packaging and delivery

Item	Details
Selling Units	Single item
Packaging Details	100pcs/carton
Carton Size & G.Weight	NW:9.8kgs ,GW:10.8kgs
Single package size	50X32X32 cm
Single gross weight	11.000 kg
Port of dispatch	Cambodia

Supply capacity

Item	Details
Supply Ability	50,000 pieces per Month

Procurement Information

Minimum order quantity: 50,000pieces

Customization options

Supplier’s customization ability

Shipping

MEDTECS (TAIWAN) CORP. - As a Manufacturer, we produce a wide range of products including AAMI Level 4 Yellow Isolation Gowns With Tape, Impermeable Gown,Decontamination Gown,Disposable Surgical Gowns,AAMI Level 4 Surgical Gowns, and Coveralls

Medtecs International Corporation Limited is the world’s leading supplier of personal protective equipment (PPE) and a trusted multi-national PPE stockpiling solutions provider to governments and group purchasing organizations around the world.

AAMI Level 4 Gown, FDA Registered & Compliant

Source your AAMI Level 4 gowns from a trusted, compliant manufacturer. The Medtecs IL-4036YKTP is an FDA-registered, AAMI Level 4 isolation gown that meets the highest standards for protection and quality, making it a reliable choice for your “approved list” of hospital supplies.

Full Compliance for Your Approved List

This gown comes with the documentation and quality assurances you need for procurement. It is a fully compliant AAMI Level 4 garment.

FDA Registered Establishment: Manufactured by Medtecs, an FDA-registered company.
ISO 13485 Certified: Our quality management system is certified for medical devices.
AAMI Level 4: Certified to the highest fluid and viral barrier standard.
ASTM F1671 & F1670 Compliant: Passes all required tests.

Key Features for Hospital Approval

This gown meets the technical specifications that Infection Control and clinical leaders demand:

Fully Taped Seams: The critical feature for an impervious barrier.
PE-Coated Fabric: 100% waterproof, 36gsm durable material.
Knit Cuffs & Tie-Back: The preferred design for clinical staff.

A Reliable Partner

Choose a gown from a reliable global supplier. The IL-4036YKTP ensures you are providing your staff with compliant, high-quality protection for ICUs, ERs, and isolation units.

AAMI PB70 Certified

FDA Registered

Manufacturer of AAMI Level 1~4
Isolation Gowns

Trusted global supplier of medical-grade PPE solutions. Meeting the highest standards for healthcare institutions worldwide with FDA, CE, and ISO certified protective equipment.

500M+

Gowns Delivered

Download Catalog

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FDA Registered Facility

ISO 13485 Certified

CE Marked Products

Level 2

AAMI PB70

24/7

Support

Understanding AAMI PB70 Standards & Our Certifications

Trust begins with transparency. Our products meet the strictest medical regulatory requirements with comprehensive international certifications.

What are AAMI Gown Levels? A Visual Guide

Level 1

Minimal Risk

Basic care, standard isolation, visitor use

Level 2

Low Risk

Blood draws, suturing, ICU, pathology lab

Level 3

Moderate Risk

Arterial blood draws, ER, trauma cases

Level 4

High Risk

Long surgeries, high fluid procedures

AAMI Level 2 Gown Protection Explained

Level 2 protection provides critical barrier function in low to moderate fluid risk environments. Perfect for most clinical settings including blood draws, suturing, ICU care, and pathology labs where fluid exposure is limited but protection is essential.

Our Compliance: FDA, CE, ISO & ASTM Certifications

FDA Registered

FDA establishment registration ensures compliance with US medical device regulations

CE Marking

Conforms to European health, safety and environmental protection standards

ISO 13485

Quality management systems for medical devices certification

ASTM Standards

Meets ASTM F1671 liquid penetration and F1670 blood penetration tests

Certified & Compliant

Level 4 Isolation Gown: Technical Specifications & Material

Complete technical data for procurement and evaluation. Detailed specifications covering material performance, sizing, and packaging information.

Protection Level

AAMI Level 4

Low to moderate fluid risk protection

Material Options

SMS / PE / SMMS

Multi-layer protective fabrics

Sizes Available

S, M, L, XL, XXL

Universal fit for all body types

Packaging

10/50/100 pcs

Flexible bulk packaging options

A Deep Dive into Our Protective Gown Fabric

SMS Multi-Layer Construction

Our advanced SMS (Spunbond-Meltblown-Spunbond) fabric technology creates the perfect balance between protection and comfort. The microscopic structure features three distinct layers working in harmony.

Key Material Features:

Three-layer SMS construction for optimal barrier protection

Breathable yet impermeable to liquids and microorganisms

Soft, comfortable fabric that reduces skin irritation

Reinforced seams and stress points for durability

Elastic or knit cuffs for secure fit and protection

Full back coverage with tie or snap closures

Fabric Weight

35-50 GSM

Optimized for Level 2 protection

Explore Our Disposable Gown Series: Filter by Design

Every clinical setting has unique needs. This guide allows you to explore the various design and customization options for our AAMI Level 2 isolation gowns. Select your preferred features to configure a gown that perfectly matches your team's requirements.

Filter by Cuff Design: Knit, Elastic & Thumb Loop Options

The interface between the gown sleeve and glove is a critical barrier. Choose the cuff design that best meets your procedural needs.

🧤

Knit Cuffs

Soft, absorbent knit cuffs for maximum comfort during long procedures

Maximum comfort

Excellent absorbency

Gentle on skin

💪

Elastic Cuffs

Classic elastic cuffs providing a secure, snug fit

Secure fit

Easy to don

Cost-effective

👍

Thumb Loop

Integrated thumb loops ensure sleeves never ride up for unbroken protection

Prevents sleeve migration

Enhanced barrier

Hands-free security

Filter by Neck & Back Closure: Tie, Velcro & Full Coverage Options

A secure closure is key to proper gown fit and protection. Compare our closure options to find the best fit for your facility.

Closure Type	Adjustability	Donning Speed	Best For
Tie Closure	High	Standard	Maximum adjustability and custom fit
Velcro Closure	Medium	Fast	Quick donning and doffing

Back Coverage Options

Full Back Coverage

360-degree protection for maximum barrier integrity

Open Back Design

Enhanced ventilation for comfort during extended wear

Filter by Waist Ties & Color-Coding Options

Ensure a secure, gap-free fit with integrated waist ties. Enhance safety protocols with color-coding for visual identification.

Waist Tie Security

🎀

Our integrated waist ties provide a secure, adjustable fit that eliminates gaps and ensures complete coverage during procedures.

Secure, gap-free protection

Customizable fit for all body types

Enhanced comfort during movement

Color-Coding System

Select your color to align with your facility’s infection control protocols:

Medical Blue

Standard hospital use, general procedures

Safety Yellow

Contact precautions, visual identification

Choosing Your Gown: Key Comparisons for Procurement

Strategic procurement requires comprehensive analysis. Compare options across total cost of ownership, infection control, and operational requirements.

Disposable vs. Reusable Isolation Gowns (TCO Analysis)

Strategic comparison focusing on financial and operational procurement pain points

Decision Factor	Disposable Gowns	Reusable Gowns
Initial Cost per Unit	Lower ($1-3)	Higher ($15-30)
Total Cost of Ownership (TCO)	Higher over time	Lower after 50+ uses
Infection Control Risk	Minimal - single use	Higher - reprocessing risk
Supply Chain Stability	Consistent availability	Dependent on laundering
Storage Requirements	Higher volume needed	Lower inventory space
Environmental Impact	Higher waste generation	Lower waste per use
Compliance Complexity	Simple - no reprocessing	Complex validation required

Disposable Gowns Recommended For:

•High-risk infection control environments

•Emergency or surge capacity situations

•Facilities without reliable laundry systems

•Regulatory compliance priority

Reusable Gowns Suitable For:

•Long-term cost optimization goals

•Established laundry/sterilization systems

•Environmental sustainability priorities

•Lower infection risk environments

Isolation vs. Patient vs. Exam Gowns

Understanding the differences between isolation gowns, patient gowns, and examination gowns

Isolation Gowns (AAMI Rated)

Full-coverage protective equipment for healthcare workers. Rated by AAMI PB70 standards for fluid barrier protection. Used in clinical settings where contamination risk exists. Available in Levels 1-4 based on protection requirements.

Patient Gowns

Designed for patient comfort and easy access during examinations and procedures. Not rated for protection. Focus on dignity, comfort, and clinical access. Typically made from soft, breathable materials for patient comfort during hospital stays.

Examination Gowns

Lightweight disposable gowns for routine examinations. Minimal protection, primarily for modesty and basic cleanliness. Used in outpatient and general practice settings. Cost-effective solution for high-volume, low-risk environments.

User Safety: A Guide to Donning & Doffing PPE Gowns

Comprehensive safety guidelines ensuring proper use and maximum protection. Following CDC protocols for healthcare worker safety and infection control.

Step-by-Step Donning & Doffing Protocol (SOP)

Donning Procedure

Hand Hygiene

Perform hand hygiene using alcohol-based hand rub or soap and water

Gown Selection

Select appropriate size gown, check for tears or damage before use

Gown Application

Put on gown, ensure full coverage of torso from neck to knees and arms to wrist

Secure Ties

Tie gown securely at neck and waist, ensure no gaps in coverage

Additional PPE

Apply other PPE as required (gloves, mask, eye protection) following facility protocol

Doffing Procedure

Remove Gloves First

Remove gloves using proper technique, perform hand hygiene immediately

Untie Waist Ties

Untie waist ties while keeping gown away from body

Remove Gown

Pull gown away from neck and shoulders, turning inside out as removed

Roll and Dispose

Roll gown with contaminated side inward, dispose in designated medical waste container

Final Hand Hygiene

Perform thorough hand hygiene after gown removal and before touching clean surfaces

Healthcare worker demonstrating proper gown donning procedure

Proper PPE Protocol Demonstration

Critical Safety Reminders

Never touch the outside of the gown during removal - always assume contamination.

Always perform hand hygiene before and after gown use.

Replace immediately if gown becomes torn or heavily soiled.

Common Use Cases in Healthcare Settings

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Intensive Care Unit (ICU)

Moderate Risk

•Patient care with contact precautions

•Blood pressure monitoring

•IV insertion and maintenance

🔬

Blood Draw/Laboratory

Low-Moderate Risk

•Venipuncture procedures

•Specimen handling

•Laboratory processing

🚨

Emergency Department

Moderate Risk

•Wound care and suturing

•Trauma assessment

•Isolation procedures

🧬

Pathology Laboratory

Moderate Risk

•Tissue processing

•Specimen examination

•Autopsy assistance

Safety Precautions & Disposal Guidelines

Pre-Use Inspection

• Check gown for tears, holes, or defects before use
• Ensure proper size selection for full body coverage
• Verify expiration date and sterility if required
• Confirm appropriate protection level for procedure

During Use

• Avoid touching contaminated surfaces with gown
• Do not adjust or readjust gown during procedure
• Replace immediately if torn or heavily contaminated
• Follow proper movement techniques to prevent breach

Disposal & Waste Management

• Dispose in designated medical waste containers only
• Never reuse disposable isolation gowns
• Follow facility protocols for medical waste segregation
• Ensure proper waste container labeling and tracking

Explore Our Full Range of Medical Gowns & Surgical Apparel

Comprehensive protective solution portfolio. From basic isolation to sterile surgery, we provide complete PPE solutions for every healthcare setting and requirement.

AAMI Isolation Gowns (Levels 1-4)

Complete range of AAMI-rated protection levels for every healthcare scenario

AAMI Level 1

Available

Minimal risk procedures, basic care

AAMI Level 2

Featured

Custom Order

Low to moderate risk, blood draws, ICU

AAMI Level 3

Available

Moderate risk, arterial procedures, ER

AAMI Level 4

Available

High risk, surgical procedures

Sterile Surgical Gowns for Advanced Procedures

Premium sterile gowns designed for operating rooms and sterile environments

Standard Sterile Gowns

Available

General surgical procedures

Reinforced Surgical Gowns

Available

Extended surgical procedures

High-Performance Gowns

Available

Complex cardiovascular surgery

Specialty Procedure Gowns

Custom Order

Orthopedic and trauma surgery

Personal Protective Apparel (PPE)

Comprehensive PPE solutions providing head-to-toe protection for healthcare teams

😷

Medical Face Masks

Available

Type I, II, IIR surgical masks

🧤

Nitrile Examination Gloves

Available

Powder-free, latex-free protection

🧢

Protective Caps & Covers

Available

Hair and head protection

👟

Shoe Covers & Booties

Available

Waterproof foot protection

Recommended Product Combinations by Healthcare Setting

🏥

Standard Hospital Care

High Volume

Surgical Procedures

Medium Volume

Emergency & Trauma

Variable Volume

Laboratory Work

Consistent Volume

Need a Custom PPE Solution?

Our product specialists can help design the perfect PPE program for your facility. From product selection to supply chain optimization.

Frequently Asked Questions (FAQ)

Get answers to common procurement questions. From ordering processes and customization options to logistics and partnership details.

Common Questions & Answers

Comprehensive answers to help streamline your procurement process

What is the MOQ for custom orders?

Minimum order quantities vary by product and customization level. Standard AAMI Level 2 gowns typically require 10,000 pieces minimum. Custom branded or specialized products may have different requirements. Contact our sales team for specific MOQ details for your project.

What are your lead times for bulk orders?

Standard orders ship within 15-20 business days. Custom orders typically require 30-45 days depending on specifications. We maintain strategic inventory for faster fulfillment of standard products and offer expedited production for emergency needs.

Do you provide private label or OEM services?

Yes, we offer comprehensive OEM and private label services including custom packaging, branding, and product specifications. Our team works with you through design, compliance, and production to create products that meet your exact requirements.

How can I request a sample or a quote?

Samples and quotes are available through our sales team. Contact us via email or phone with your specific requirements including quantities, specifications, and delivery location. Sample shipments typically process within 1-2 business days.

What certifications do your products carry?

All our products are manufactured in FDA-registered facilities and carry CE marking for European markets. Our isolation gowns meet AAMI PB70 standards and comply with ASTM F1670 and F1671 testing requirements. ISO 13485:2016 certified quality management systems ensure consistent production quality.

Do you offer emergency or surge capacity ordering?

Yes, we maintain emergency response protocols and backup production capacity for surge demand situations. Our global manufacturing network allows us to rapidly scale production and expedite shipping for critical healthcare needs. Contact our emergency ordering line for immediate assistance.

What are your payment terms and conditions?

We offer flexible payment options including T/T (Telegraphic Transfer) and L/C (Letter of Credit). Standard terms are 30% deposit with balance before shipment. Established clients may qualify for extended terms. We're open to discussing arrangements that fit your procurement processes.

How do you ensure consistent product quality?

Quality is maintained through ISO 13485 certified processes, automated quality control at every production stage, real-time batch tracking, and comprehensive testing including ASTM F1670/F1671 compliance. Every shipment includes certificates of compliance and testing documentation.

Ready to Start Your Order?

Join hundreds of healthcare facilities who trust our reliable supply chain and quality products. Get started with a sample request or custom quote today.

AAMI Level 4 Gown, Approved List, FDA

FDA Registered & Compliant Level 4 Gown

Approved / Certified Gown Attributes

Packaging and delivery

Supply capacity

Procurement Information

Minimum order quantity: 50,000pieces

Customization options

Supplier’s customization ability

Shipping

MEDTECS (TAIWAN) CORP. - As a Manufacturer, we produce a wide range of products including AAMI Level 4 Yellow Isolation Gowns With Tape, Impermeable Gown,Decontamination Gown,Disposable Surgical Gowns,AAMI Level 4 Surgical Gowns, and Coveralls

TAG

AAMI Level 4 Gown, FDA Registered & Compliant

Full Compliance for Your Approved List

Key Features for Hospital Approval

A Reliable Partner

Manufacturer of AAMI Level 1~4Isolation Gowns

Understanding AAMI PB70 Standards & Our Certifications

What are AAMI Gown Levels? A Visual Guide

AAMI Level 2 Gown Protection Explained

Our Compliance: FDA, CE, ISO & ASTM Certifications

FDA Registered

CE Marking

ISO 13485

ASTM Standards

Level 4 Isolation Gown: Technical Specifications & Material

A Deep Dive into Our Protective Gown Fabric

SMS Multi-Layer Construction

Key Material Features:

Explore Our Disposable Gown Series: Filter by Design

Filter by Cuff Design: Knit, Elastic & Thumb Loop Options

Knit Cuffs

Elastic Cuffs

Thumb Loop

Filter by Neck & Back Closure: Tie, Velcro & Full Coverage Options

Back Coverage Options

Full Back Coverage

Open Back Design

Filter by Waist Ties & Color-Coding Options

Waist Tie Security

Color-Coding System

Choosing Your Gown: Key Comparisons for Procurement

Disposable vs. Reusable Isolation Gowns (TCO Analysis)

Disposable Gowns Recommended For:

Reusable Gowns Suitable For:

Isolation vs. Patient vs. Exam Gowns

Isolation Gowns (AAMI Rated)

Patient Gowns

Examination Gowns

User Safety: A Guide to Donning & Doffing PPE Gowns

Step-by-Step Donning & Doffing Protocol (SOP)

Donning Procedure

Hand Hygiene

Gown Selection

Gown Application

Secure Ties

Additional PPE

Doffing Procedure

Remove Gloves First

Untie Waist Ties

Remove Gown

Roll and Dispose

Final Hand Hygiene

Critical Safety Reminders

Common Use Cases in Healthcare Settings

Intensive Care Unit (ICU)

Blood Draw/Laboratory

Emergency Department

Pathology Laboratory

Safety Precautions & Disposal Guidelines

Pre-Use Inspection

During Use

Disposal & Waste Management

Explore Our Full Range of Medical Gowns & Surgical Apparel

AAMI Isolation Gowns (Levels 1-4)

Sterile Surgical Gowns for Advanced Procedures

Personal Protective Apparel (PPE)

Recommended Product Combinations by Healthcare Setting

Standard Hospital Care

Recommended Products:

Manufacturer of AAMI Level 1~4
Isolation Gowns