HI-RISK RESPONDER PLUS CERTIFICATIONS

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PROVEN BARRIER AGAINST CHEMICAL EXPOSURE 100-COUNT BOXES SAVE SPACE, TIME & WASTE FENTANYL PERMEATION TESTED (ASTM D6978) HIGHLY RESISTANT TO PUNCTURES & TEARS ISO 13485 QUALITY SYSTEM STANDARDS RELIABLE HAZARD PROTECTION

LATEX

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LATEX

by PERFORMANCESAFETYGROUP

NITRILE MEDICAL GRADE EXAM GLOVES Extended Cuff with 8.25 mil Fingertip Thickness Resists Permeation of Fentanyl (ASTM D6978) Proven Defense Against Chemical Exposure 0.65 AQL for Advanced Barrier Protection UL certified NFPA 1999-2018 edition Country of Origin: Malaysia General General Description: Description: Material: Nitrile Butadiene Rubber (NBR) Color: Violet Blue or Blue Interior: Powder-Free Exterior: Finger Textured Cuff: Extended, Beaded

Type: Usage: Shape: Sizes: Process:

Non-Sterile Single-Use Ambidextrous XS - 3X Chlorinated

Physical Properties:

Resistant to Fentanyl:

Tensile Strength (Unaged): 31 MPa min Elongation (Unaged): Tensile Strength (Aged): 28 MPa min Elongation (Aged): Powder Content: Powder-Free Shelf Life: Freedom From Holes: 0.65 AQL FDA Listing: Allergy Prevention: Latex (TYPE 1) Standard:

Dimensions:

700% 600% 5 Years 510(k) ASTM D6319

Enviro-Responsible Packaging:

Size MD Weight: 8.8 gm ± .03 Thickness - Cuff: .11 mm ± .02 Palm: .14 mm ± .02 Finger: .21 mm ± .02

Sustainably Sourced Recycled Paperboard Saves Time, Space, Money & the Environment

100% Recycled Box: 100 gloves/ box

2X-3X = 90/ box

Box Dims: 251 x 129 x 75 mm 100% Recycled Case: 1,000 gloves/ case Case Dims: 445 x 255 x 255 mm

Width - X-Small:

71-80 mm

Small:

81-89 mm

Medium:

90-99 mm

Product Codes:

Large: 100-109 mm

X-Small: Small: Medium: Large: X-Large: 2X-Large: 3X-Large:

Boxes & Cases Are Barcoded & Contain Dated Lot Codes for Quality Assurance & Traceability

X-Large: 110-119 mm 2X-Large: 120-128 mm 3X-Large: 126-134 mm Length: 300 ± 10 mm

Meets or exceeds NIOSH recommendations for Fentanyl and its analogues. ASTM D6978 laboratory tests confirm no permeation of Fentanyl or gastric acid (vomit) when exposed for up to 240 minutes (test limit). Results on file.

Standards & Certifications: RESPONDER SERIES are ISO 9001 and 13485 certified, ensuring that our product requirements reach beyond the normal quality system standards. Inspected in compliance with Good Manufacturing Practices, surpassing those of the industry standard established by the American Society for Testing and Materials (ASTM) and FDA Quality System Regulation (QSR) to ensure consistent glove performance.

Meets or exceeds emergency medical glove requirement of NFPA 1999-2018 Ed. Standard for Emergency Medical Operations. RESPONDER SERIES are ASTM D6978-05 tested for use with cytotoxic or chemotherapy drugs.

PROTECTIVE SINGLE-USE EXAMINATION GLOVES FOR EMERGENCY MEDICAL OPERATIONS IN ACCORDANCE WITH THE NATIONAL FIRE PROTECTION ASSOCIATION STANDARD ON PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS, NFPA 1999-2018.

DNPF-701-XS DNPF-701-S DNPF-701-M DNPF-701-L DNPF-701-XL DNPF-701-2X DNPF-701-3X

THIS GLOVE IS FOR SINGLE USE ONLY! THIS GLOVE MEETS THE SINGLE-USE EMERGENCY MEDICAL EXAMINATION GLOVE REQUIREMENTS OF NFPA 1999, STANDARD ON PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS, 2018 EDITION.

Recommended Industries:

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© Copyright 2021 Performance Safety Group, Inc.

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CONFIDENTIAL CERTIFICATE OF COMPLIANCE Issue Date

20170929- MH47713 MH60153-20170927 2017-SEPTEMBER-29

Issued to:

(MALAYSIA) SDN BHD

Certificate Number Report Reference

Selangor MALAYSIA This is to certify that representative samples of

PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS Protective Gloves, Models: Violet Blue Nitrile Examination Glove, Low Dermatitis Potential, Light Blue Nitrile Examination Glove, Low Dermatitis Potential Have been investigated by UL in accordance with the Standard(s) indicated on this Certificate.

Standard(s) for Safety: Additional Information:

NFPA 1999-2018, Protective Clothing and Ensembles for Emergency Medical Operations See the UL Online Certifications Directory at www.ul.com/database for additional information

Only those products bearing the UL Certification Mark should be considered as being covered by UL's Certification and Follow-Up Service.

Look for the UL Certification Mark on the product.

Bruce Mahrenholz, Director North American Certification Program UL LLC Any information and documentation involving UL Mark services are provided on behalf of UL LLC (UL) or any authorized licensee of UL. For questions, please contact a local UL Customer Service Representative at http://ul.com/aboutul/locations/

Page 1 of 1

• CONFIDENTIAL • AKRON RUBBER DEVELOPMENT LABORATORY, INC.

Progress Through Innovation, Technology and Customer Satisfaction

February 5, 2018

• TEST REPORT • PN 139349 CHEMICAL ANALYTICAL SERVICES Ms. Cho Sow Fong

Malaysia

An A 2 L A ISO 17025 Accredited Testing Laboratory - Certificate Numbers 255.01 & 255.02 ISO 9001 :2008 Registered

I S O 9001:2008

A Testing Lab !, 0 .J ':l) ' ° -c..t,nu,t,e N!.lm�fI 1 &:l".02

Letters and reports are for the exclusive use of the clients to whom they are addressed and shall not be reproduced, except in full, without the written permls&lon of Akron Rubber Development Laboratory, Inc. (AR0L). Tho 1nrormat1on conta1nod horoin applies to tho spoc1fic matonat, products or prOCCl:i!iOS tested or ovaluatod. No warranty or any kind is hure,n construed or 1mphed. Tho IIAblllty of ARDL, Inc. shall be limited to the amount of consideration paid for services. AR0L, Inc. is ISO 17025 accredited by A2LA for the test methods listed on the referenced certificates.

www.ardl.com I 2887 Gilchrist Rd. I Akron, Ohio 44305 I answers@ardl.com IToll Free (800) 830-ARDL Fax (330) 794-6610 IWorldwide (330) 794-6600

Progress Through Innovation, Technology and Customer Satisfaction

AKRON RUBBER DEVELOPMENT LABORATORY, INC.

February 5, 2018

Cho Sow Fong Page 1 of 2 - PN .139349

SUBJECT:

Permeation testing per ASTM D 6978 on sample submitted by the above company.

RECEIVED:

One (1) Glove type identified as; PF Nitrile, Blue-Colored, Non-Sterile, Low Dermatitis Potential, Lot# 14027902.

TEST DRUG: Table 1. List of the Testing Drugs, Sources, and Expiration Dates TESTING DRUG Fentan I Citrate In·ection, 100mc /2mL

DRUG SOURCE Hos ira; Lot# 80-337-DK; Ex iration 2/1/2019

COLLECTION MEDIA: The collection media, which were selected, are listed in Table 2.

Table 2. Collection Media for Testing Drugs TEST DRUG AND CONCENTRATION Fentan I Citrate ln'ection, 100mc /2mL

TESTING CONDITIONS: Standard Test Method Used: Deviation from Standard Test Method: Analytical Method: Testing Temperature: Collection System: Specimen Area Exposed: Selected Data Points: Number of Specimens Tested: Location Sampled From:

COLLECTION MEDIUM Distilled Water

ASTM D 6978 Used 1" Permeation Cell UVNIS Spectrometry 35.0 ° C ± 2.0 Closed Loop 5.067 cm2 25/test 3/test Cuff area

www.ardl.com I 2887 Gilchrist Rd. I Akron, Ohio 44305 I answers@ardl.com IToll Free {800} 830-ARDL Fax (330) 794-6610 IWorldwide (330) 794-6600

Cho Sow Fong Page 2 of 2 - PN 139349

DETECTION METHOD OF CHEMICAL PERMEATION: UVNIS ABSORPTION SPECTROMETRY:

Instrument: Perkin Elmer UVNIS Spectrometer Lambda 25 UVNIS Absorption Spectrometry was used to measure the absorbance of test chemicals, which permeated through the specimens into the collection medium. The collection medium was circulated in a closed loop at 11 ml/minute of flow rate through the testing period. Data collection was performed according to the programmed schedule by means of UV Winlab software from the Perkin Elmer Corporation. The list of the characteristic wavelengths is shown below.

Table 3. Characteristic Wavelengths used in UVNIS Absorption Spectrometry

TEST DRUG

WAVELENGTH nm 199

Fentan I Citrate ln'ection, 100mc /2mL

SAMPLE CHARACTERISTICS: Table 4. Thickness characteristics for the tested specimens: PF Nitrile, Blue-Colored, Non-Sterile, Low Dermatitis Potential, Lot# 14027902.

Testing Drug Fentanvl Citrate

Thickness (mm) Sample 1 I Sample 2 I Sample 3 0.053 0.053 0.054

I

I

Average (mm) 0.053

Weight/Unit Area (g/m2) 50.6

RESULTS: Table 5. Permeation Test Results on: PF Nitrile, Blue-Colored, Non-Sterile, Low Dermatitis Potential, Lot# 14027902.

TEST DRUG AND CONCENTRATION Fentanyl Citrate Injection, 100mcg/2mL

MINIMUM BREAKTHROUGH DETECTION TIME (Specimen 1/2/3) (Minutes)

STEADY STATE PERM.RATE (Specimen 1/2/3) (µg/cm 2/minute)

OTHER OBSERVATIONS

>240

0

Slight swelling and no degradation

Tiffany L Heller

Assistant Manager, Pharmaceutical Services

AKRON RUBBER DEVELOPMENT LABORATORY, INC.

Ana C. Barbur, M.S, Vice President, Analytical Services

Dear Performance Safety Group: This e-mail provides confirmation that the annual registration for the following medical device establishment has been successfully completed for 2021: Registration Number: 3009305903 Owner Operator Number: 10041459 PERFORMANCE SAFETY GROUP, INC. 781A Rudder Rd. Fenton, MO 63026 UNITED STATES

If you do not see a registration number assigned to the establishment and your establishment previously had one, please send an email to reglist@cdrh.fda.gov and include the registration number you believe is assigned to your establishment. We will review and determine if a duplicate registration has been created for your establishment.

Your registration is valid until December 31, 2021. Registration for 2022 will be conducted between October 1 and December 31, 2021.

Please note that registering your device facility and listing your devices does not, in any way, constitute FDA approval of your facility or your devices.

Should you have any questions, please send an e-mail to the CDRH Registration and Listing Helpdesk at reglist@cdrh.fda.gov.

CDRH Registration and Listing Helpdesk Office of Compliance Center for Devices and Radiological Health U.S. Food and Drug Administration Email: reglist@cdrh.fda.gov

id: 156367

Licence Number

13017

Numéro de la licence

Medical Device Establishment Licence

Licence d'établissement pour les instruments médicaux

PERFORMANCE SAFETY GROUP I, LP PERFORMANCE SAFETY GROUP 781A RUDDER ROAD ST. LOUIS, MISSOURI UNITED STATES 63026 Cette licence est délivrée conformément à la Loi sur les aliments et drogues, règlement sur les instruments médicaux pour les activités qui suivent:

This licence is issued in accordance with the Medical Devices Regulations of the Food and Drugs Act for the following activities: Distributor / Distributeur Class I / Classe I Class II / Classe II Class III / Classe III Class IV / Classe IV

Importer / Importateur

Yes / Oui

No / Non

Yes / Oui No / Non

No / Non

No / Non

No / Non

Yes / Oui

No / Non

Attestation made :

Attestations faites : L'établissement a mis en oeuvre une procédure écrite concernant: les registres de distribution les plaintes les rappels rapports d'incident obligatoires la manutention, le stockage, la livraison l'installation, les mesures correctives

The establishment has documented procedures in place in respect of: distribution records complaint handling recalls mandatory problem reporting handling, storage, delivery installation corrective action servicing

Site listing begins on the back of this page Issue Date, date de délivrance: 2020-08-07 Minister of Health Ministre de la santé

Manufacture Devices for Distribution / Fabricant d'instruments médicaux pour distribution

[Y] [Y] [Y] [N] [Y] [N] [N] [N]

l'entretien

Liste des sites commence au verso de cette page

Countersigned: Director, Medical Devices Compliance Program or delegated authority Contresigné par: Directeur, Programme de la conformité des matériels médicaux ou autoritée déléguée

Chad Sheehy This licence is the property of the Medical Devices Compliance Program and must be returned upon demand.

Cette licence appartient au Programme de la conformité des matériels médicaux et doit être retournée sur demande.

Satisfied Customers

PerformanceSafetyGroup

I

877.PSG.4568

I

PSGgear.com

Satisfied Customers

PerformanceSafetyGroup

I

877.PSG.4568

I

PSGgear.com

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

PSGGEAR.COM

SINGLE-USE

EXAM GLOVES MEDICAL GRADE

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

COVID-19

FACE SHIELD INFECTION-CONTROL

SINGLE-USE FACE MASKS

to those risking their lives to save ours: Our Healthcare Workers and First Responders.

Thank You, Healthcare Heroes