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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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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:
POLICE
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MANUFACTURING
© 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