ISOLATION GOWNS • ANSI/AAMI PB70 FDA CERTIFIED • LEVEL 1-4 • SINGLE-USE & REUSABLE OPTIONS

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ISOLATION GOWNS

Single-Use • Reusable • Levels 1-4

For samples or more information, contact your Performance Safety Group Sales Representative at 877-774-4568 or COVID-19@PSGGEAR.com. © Copyright 2020 Performance Safety Group, Inc.


Material Descriptions

AAMI Level 1 to AAMI Level 4

Spunbond Polypropylene SPUNBOUND

Standard, Cost-Effective and Comfortable For basic infection control, this non-woven fabric bonds fibers together to form a single layer that is appropriate only for very minimal fluid exposure.

SMS Material Balanced mix of protection and comfort

SPUNBOUND

Strong and breathable, Spunbond/Meltblown/Spunbond (SMS) is a multi-layer fabric composed of inner layers of meltblown polypropylene sandwiched between strong, outer layers of spunbond polypropylene that is ideal for extended wear. Light/medium weight SMS is appropriate for low amounts of fluid and heavy weight SMS may be appropriate for moderate contact with fluids.

MELTBLOWN SPUNBOUND

Coated Polypropylene (“Poly-coated�) SPUNBOUND

Balanced mix of protection and comfort POLY FILM

Soft, spunbond polypropylene is coated with a layer of polyethylene (plastic) film.

Polyethylene (Plastic) Film POLY FILM

Basic Cover Protection A single layer of polyethylene (plastic) film provides light fluid-repelling protection at an affordable cost. Naturally low in lint and and does not meet the AAMI PB70 Standard.

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AAMI PB70 Guidelines

The Benchmark for Protection To comply with AAMI Guidelines, protective apparel must achieve minimum performance standards for strength, barrier performance and fluid resistance. Tested under controlled conditions, AAMI-rated gowns must demonstrate a 4% AQL level, which provides a high level of assurance that users are protected for the anticipated level of fluid contact. Each gown must be fully protective in the front, back and along the seams, and clearly labeled to indicate the level of protection provided, from AAMI PB70 Level 1 (lowest) to AAMI Level 4 (highest). The entire PSG portfolio of Isolation Gowns are manufactured in FDA QSR-compliant, ISO 13485 certified facilities and meet all AAMI PB70 specifications for Level 1, 2, 3 and 4 protection. Table 1: Summary of AAMI Fluid Resistance Classification (Adapted from AAMI PB70:2012)

AAMI LEVEL 2 Fluid Resistant

AAMI LEVEL 3 Fluid Resistant

AAMI LEVEL 4 Fluid Impermeable

Minimum standard for isolation gowns for minimal amounts of spray or droplets

Commonly used as an isolation gown. Suitable for settings with low amounts of fluid or sprays

Appropriate where more moderate levels of fluid exposure or sprays are anticipated

Used where large amounts of fluids or sprays may be anticipated or encountered

Spunbond non-woven product

Single Layer microfibres or a topically treated textile material

Laminated or coated material (e.g. polypropylene coated polypropylene)

Laminated or coated material (e.g.impervious polyethylene

Resistance to Fluid Penetration

Minimal water resistance

Resistant to water spray and some resistance to water absorption on contact

A higher standard of resistant to water spray and water absorption on contact compared to Level 2

Resistant to the penetration of viruses based on penetration of a surrogate microbe

Resistance to Fluid Penetration test

AATCC 42-2017: Test for spray resistance

AATCC 42-2017 AATCC 127 Test for water resistance > 20 cm hydrostatic pressure

AATCC 42-2017 AATCC 127 Test for water resistance > 50 cm hydrostatic pressure

Meets requirements of bacteriophage penetration ASTM F1671

Characteristics

Application

Material

AAMI LEVEL 1 Fluid Resistant

• AATCC 42-2017: Measures resistance of fabrics to the penetration of water by impact (AATCC, 2018) • AATCC 127-2017: Measures resistance of fabric to the penetration of water under hydrostatic pressure (AATCC, 2017) • ASTM F1670-17: Evaluate resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact (ASTM, 2017) • ASTM F1671-13: Measure penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact (ASTM, 2013)

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LEVEL 1& 2

REUSABLE • ECO-FRIENDLY

The Math Is Simple. 20-30 Disposable Gowns or One Reusable? When you choose reusables, you reduce waste and waste costs. Reusables are the smart and environmentally responsible choice!

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THE MATH IS SIMPLE Reusable Isolation Gowns Affordable, environmentally-friendly option

The Environmentally Preferable Choice over Single-Use Disposable Items. SAVINGS - reduce costs by lasting through multiple processings

EFFICIENCY - fewer orders and deliveries than disposables

SUSTAINABILITY - reduces regulated medical waste by an average of 65 percent!

DEPENDABLE - laboratory tests conďŹ rm gowns withstand over twenty washings

TESTED - meet STANDARD 100 by OEKO-TEX for harmful substances


ISOLATION GOWN REUSABLE • ECO-FRIENDLY

REUSABLE, SUSTAINABLE ISOLATION GOWN LEVEL

1

LATEX

CERTIFICATION

The Environmentally Responsible Choice over single-use, disposable gowns • 50% cotton / 50% polyester broadcloth for maximum comfort • Laboratory tested for over 25 washings • Overlap back, twill tie neck and waist closures • 54” Sweep - 44” Length - 2.6 oz. per square yard fabric • Ideal for acute care and long-term healthcare environments

Lightweight Protection Cost-Effective, Safe & ‘Green’ Option

e

• Compare to MEDLINE MDT012204 • ANSI/AAMI PB70 Level 1, OEKO-TEX 100, ISO/IEC 17050I • Item #: ISOGWY-4454 / One size fits most / 10/pk, 100/cs


ISOLATION GOWN ECONOMICAL

SINGLE-USE ISOLATION GOWN LEVEL

LATEX

1

CERTIFICATION

Affordable solution for protection against fluids and microorganisms under light-pressure conditions • 45 GSM PP+PE multilayer non-woven material • High levels of chemical resistance and abrasive strength • Long sleeves, waist tie, elastic wrists and neck Velcro closure • Strong, sealed seams withstand fluids under light conditions • Used for general patient care, clinical use and housekeeping • Compare to MEDLINE NONLV100 • Meets ANSI/AAMI PB70 and AATCC 42 Level 1 standard • Item #: ISOGWB1 / S-XL or Universal / 10/pk, 100/cs

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ISOLATION GOWN ECONOMICAL

SINGLE-USE ISOLATION GOWN LEVEL

1

LATEX

CERTIFICATION

Comfortable, breathable and lightweight design recommended for procedures with low exposure to fluids • 45 GSM PP+PE multilayer non-woven material • Generously sized for full coverage and flexibility • Long sleeves, waist tie, elastic wrists and neck Velcro closure • Strong sealed seams to withstand even rough treatment • Ideal for transporting patients, laundry and clinical use • Compare to MEDLINE NONLV100 • Meets ANSI/AAMI PB70 and AATCC 42 Level 1 requirements • Item #: ISOGWY1 / S-XL or Universal / 10/pk, 100/cs

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One of the greatest challenges healthcare providers face is moving toward a more sustainable, environmentally-friendly culture, while ensuring patient and staff protection and comfort.

REUSABLE • ECO-FRIENDLY

The Math Is Simple. 20-30 Disposable Gowns or One Reusable? When you choose cost-effecient reusables, you reduce waste and associated waste costs. Reusables are smartly designed for healthcare and the environmentally responsible choice!

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REUSABLE • ECO-FRIENDLY

BREATHABLE, REUSABLE LIQUID-RESISTANT ISOLATION GOWN LEVEL

2

LATEX

CERTIFICATION

The Environmentally Responsible Choice offering healthcare workers 360-degree protection • 60% cotton / 40% polyester 150 GSM woven fabric • Generously sized for full coverage and flexibility • Anti-static, low lint and bounded seams for advanced protection • Offered with 2” white stockinette or elastic cuffs • Durable and holds up well to over 25 industrial launderings • ISO 9001, 14001, 45001, 10993-10, FDA and CE certified • Meets ANSI/AAMI PB70 and ASTM F3352-19 requirements • Item #: ISOGWRY / L, XL or Universal / 10/pk, 100/cs

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SINGLE-USE ISOLATION GOWN LEVEL

2

LATEX

CERTIFICATION

Protects healthcare workers against microorganisms and body fluids in low risk patient situations • 50 GSM Polypropylene (PP) + Polyethylene (PE) • Bonded seams for advanced protection • Waist tie and neck with elastic or knit wrists • Comfortable, medium weight, 100% non-woven fabric • Meets AATCC 42 & AATCC 127 Level 2 requirements • AAMI PB70 Level 2, ASTM F1671, ISO 9001, FDA certified • Item #: ISOGWY2 / S-2X or OSFM / 10/pk, 100/cs

SINGLE-USE ISOLATION GOWN LEVEL

LATEX

2

CERTIFICATION

Provides medical professionals a barrier to larger amounts of fluid penatration through splatter • 50 GSM Polypropylene (PP) + Polyethylene (PE) • Soft and breathable fabric for an excellent fit • Bonded seams for advanced protection • Generously sized for full coverage and flexibility • Medium weight, anti-static, low lint fabric • AAMI PB70 Level 2, ASTM F1671, ISO 9001, FDA certified • Item #: ISOGWB2 / S-2X or OSFM / 10/pk, 100/cs

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SINGLE-USE ISOLATION GOWN LEVEL

2

LATEX

CERTIFICATION

Tri-Layer fabric give clinicians the confidence and comfort they need to deliver the best possible patient care • Medium weight 3-layer SMS fabric • Sonically-sealed seams deliver advanced protection • Full-back, neck tape and wide tie belt • deal for dialysis, endoscopy, trauma, and ER applications • Matches Halyard BASICS Tri-Layer 43007 • AAMI PB70 Level 2, ISO 9001 & 13485, FDA certified • Item #: ISOGWBC2 / S-2X or Universal / 10/pk, 100/cs

TRI-LAYER NON-WOVEN FABRIC • Outer Layers - Spunbond polypropylene (PP) material is cloth-like, yet tough and abrasion-resistant. • Middle Layer - Intricate meltblown polypropylene micro fibers that filter out many water-based liquids.

ANSI/AAMI PB70 LEVEL 2 CERTIFIED • AATCC 127 Spray impact Penetration ≤ 1.0 g • AATCC 42 Hydrostatic Pressure ≥ 20 cm

SINGLE-USE ISOLATION GOWN LEVEL

LATEX

2

CERTIFICATION

Reduces the risk of contamination and transmission of infectious organisms that lead to HAIs • Medium weight 3-layer SMS fabric • Ultrasonic sealed seams for ultimate protection • Suitable for blood draws, suturing, ICU and pathology labs • Full-back, neck tape and wide tie belt • Matches Halyard BASICS Tri-Layer 43007 • AAMI PB70 Level 2, ISO 9001 & 13485, FDA certified • Item #: ISOGWBC2 / S-2X or Universal / 10/pk, 100/cs

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PSG ANSI/AAMI compliant Isolation Gowns are constructed PSG ANSI/AAMI compliant Gowns are constructed from durable materials that Isolation helathcare personnel depend on from durable materials that helathcare personnel on and trust for maximum protection and unmatcheddepend comfort. and non-reinforced trust for maximum and unmatched Our Levelprotection 3 gowns provide a barrier comfort. to larger Our non-reinforced Level 3 gowns provide a barrier to larger amounts of fluid penatration through splatter and more fluid amounts of fluid penatration through splatter and more fluid exposurein in moderate environments, while Level 4 gowns are exposurein in moderate environments, while Level 4 gowns are used in high risk settings when pathogen resistance is needed used in high risk settingsare when pathogenBoth resistance is exam needed or infectious diseases suspected. premium or infectious diseases from are suspected. premium exam gowns are constructed spunbond Both polypropylene (SPP), gowns are constructed from spunbond polypropylene coated with a layer of impervious of polyethylene (PE)(SPP), and coated with a layer of impervious of polyethylene (PE) and feature taped, sealed seams for high fluid and bacteria defense. feature taped, sealed fluid securing and bacteria defense. Performance Safetyseams Groupfor is high promptly additional Performance Safety Group promptly securing additional manufacturing capacity to is meet surging demand, and are manufacturing capacity to meet surging demand, dedicated to supporting those front-line caregivers and and are first dedicated to supporting those front-line caregivers and first responders treating patients during the COVID-19 pandemic. responders treating patients during the COVID-19 pandemic.

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SINGLE-USE ISOLATION GOWN LEVEL

3

LATEX

CERTIFICATION

Non-Reinforced, breathable surgical gown delivers an effective, high level of fluid protection • 42 GSM Spunbond Polypropylene (SPP) + Polyethylene (PE) Laminate • Lightweight, anti-static, low lint fabric • Taped, sealed seams offer dependable barrier protection • Polyester white cuffs that keep sleeves in place • ASTM F1671 tested against blood and bodily fluid penetration • Comparable to Cardinal Health surgical gown 9905-99 • AAMI PB70 Level 3, ASTM F2407, ISO 13485, FDA certified • Item #: ISOGWB3 / S/M-2X or Universal / 10/pk, 100/cs



IMPERVIOUS SINGLE-USE ISOLATION GOWN LEVEL

LATEX

4

CERTIFICATION

Engineered from chlorinated polyethylene elastomer (CPE) material to provide protection at an affordable price • 40 gsm CPE (chlorinated polyethylene) non-woven material • Open-back for breathability to keep wearer cool and comfortable • Long sleeves, waist tie, elastic wrists and thumbhooks • Strong, heat sealed seams withstand fluids and pathogens • Thumb loop keeps gown sleeve in place under gloves • Overhead neck closure allows quick and easy donning • Meets ANSI/AAMI PB70 and AATCC 42 Level 4 standard • Item #: ISOGWCPEB4 / Universal / 1/pk, 100/cs

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IMPERVIOUS SINGLE-USE ISOLATION GOWN LEVEL

4

LATEX

CERTIFICATION

Protects both patient and healthcare professional from possible transfer of blood, body fluids and pathogens • 42 GSM Spunbond Polypropylene (SPP) + Polyethylene (PE) Laminate • Taped, sealed seams provide exceptional fluid resistance • Exceptional fluid resistance and superb breathability • Comfortable fit with waist ties and stockinette cuffs • Premium Polyethylene coated materials tested against ASTM F1671 • ASTM F1670 compliant for blood and bodily fluid penetration • ANSI/AAMI PB70 Level 4, FDA, CE and ISO 13485/10993/45001 certified • Item #: ISOGWB4 / S-2X or Universal / 10/pk, 100/cs

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ANSI/AAMI PB70 STANDARD The Benchmark for Protection

Our Isolation Gown portfolio provides barrier protection based on AAMI guidelines and helps reduce the risk of contamination and transmission of infectious organisms that lead to HAIs. PSG ANSI/AAMI PB70:2003 Level 3 and Level 4 Certified Isolation Gowns give healthcare professionals the confidence and comfort necessary to deliver the best possible patient care. PerformanceSafetyGroup I 877 .PSG.4568 I PSGgear. com PerformanceSafetyGroup I 877 .PSG.4568 I PSGgear. com


SatisďŹ ed Customers

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SatisďŹ ed Customers

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CONTACT US Business Name: Address:

PERFORMANCESAFETYGROUP

Main: Government Division: COVID-19 PPE Hotline: Fax: Toll Free Fax:

781A Rudder Rd. St. Louis, MO 63026 636.326.4568 636.326.GOVT (4688) 877.774.4568 636.496.7022 877.774.1329

Tax ID#: Business Type: Business Classification: CAGE CODE: DUNS#:

81-4807855 Limited Partnership Manufacturer/Distributor 5Q211 849171942

NIGP CODES: NAICS CODES: SIC CODES:

47500, 34000, 34500, 20100, 17500, 48500, 16500 315990, 339113, 423450, 423840, 423990 2381, 3069, 3151, 3842, 5047, 5085, 5099

Government Division: COVID-19 Email: Purchase Orders: Website:

GOVT@PSGgear.com COVID-19@PSGgear.com ORDERS@PSGgear.com

PSG GEAR. COM

ISOLATION GOWNS Single-Use • Reusable • Levels 1-4

COVID-19

FACE SHIELD INFECTION-CONTROL

SINGLE-USE FACE MASKS

SINGLE-USE

EXAM GLOVE MEDICAL GRADE


to those risking their lives to save ours: Our Healthcare Workers and First Responders. Thank You, Healthcare Heroes


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