Personal Protective Equipment’s & Supplies · Company PJSC (Mubadala), the Abu Dhabi-based global...
Transcript of Personal Protective Equipment’s & Supplies · Company PJSC (Mubadala), the Abu Dhabi-based global...
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LIFE PLUSPersonal Protective Equipment’s & Supplies
stratauae #WeAreDedicated
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The global coronavirus (Covid-19) pandemic has had a devastating worldwide impact. As countries across the globe battle to control the spread of the virus, the finite resource pool of frontline equipment and supplies has come under scrutiny.
Increased demand for personal protective equipment (PPE), at a time when logistical supply chains are already under immense pressure, has created a global shortage for frontline healthcare workers and the general population.
As various sectors work collaboratively in the fight against COVID-19, Strata is utilising its capabilities as a leading high-quality manufacturing company to support frontline workers protecting our communities.
Our Story Strata Manufacturing PJSC (STRATA) is a composite aero-structures manufacturing facility based in the heart of Nibras Al Ain Aerospace Park in Al Ain, United Arab Emirates. Established in 2009, Strata began production in 2010. Strata has partnerships with the world’s leading aircraft manufacturers such as Airbus, Boeing and Leonardo-Finmeccanica Aerostructures Division. Strata is also a tier one supplier to Pilatus, FACC AG, SAAB and SABCA.
Strata is wholly owned by Mubadala Investment Company PJSC (Mubadala), the Abu Dhabi-based global investor, and is part of the Mubadala’s Aerospace, Renewables & ICT platform that aims to advance the development of a leading aerospace hub in the Emirate of Abu Dhabi.
Who Are We
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DISPOSABLE MASKH919 NIOSH N95
Products
Consumables
Eco-friendly & Hypoallergenic
>98% filtration efficiency against solid and liquid particlesThe new NIOSH N95 H919 mask is ergonomically designed to provide comfort and optimum protection. It provides an excellent leak-tight seal and prevents toxic particles from entering the mask. Tested by users with different face shapes, it adapts to a wide variety of facial shapes and sizes thanks to its design, to guarantee protection and comfort. The innovative design means larger interior volume, providing increased respiratory comfort to users.
Technical Specifications
User Manual
Model H919Ordering SKU ME5595N-STCertification NIOSH N95 TC-84A-8480Nose Foam YesStraps Head StrapsStrap Style WeldedSize One size fits all
Made with Pride in UAE
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>98% filtration efficiency against solid and liquid particlesThe new H910 Plus series mask is ergonomically designed to provide comfort and optimum protection. It provides an excellent leak-tight seal and prevents toxic particles from entering the mask. Tested by users with different face shapes, it adapts to a wide variety of facial shapes and sizes thanks to its design, to guarantee protection and comfort. The innovative design means larger interior volume, providing increased respiratory comfort to users.
Technical Specifications
* PPE-R/02.075 version 1 (FFP 2)EN 149 +A1 : 2009 Filtering half-mask to protect against COVID-19** Tested as per ASTM F2101*** Tested as per ASTM F2299(03):2017**** Tested as per ASTM F1862/ F1862M-17
User Manual
Products
DISPOSABLE FILTERING MASKH910 PLUS FLAT FOLD
Consumables
Model H910 PlusOrdering SKU ME5590A-MEFFP Classification FFP2*Nose Foam YesStraps Elastic (Ear loop design)Size One size fits allBacterial Filtration Efficiency 99.5%**Penetration of Particulates 98.3%***Penetration of Synthetic Blood/ Splash Resistance Yes****
Made with Pride in UAE
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PPE designed to protect the wearer’s entire face from hazards and reduce potential infections.
Technical Specifications
Assembly Instructions
Products
LIFE PLUSFACE SHIELDConsumables
Model Face ShieldMATERIALHead-band PLA/PPVisor Anti-Fog PETTECHNOLOGY FDM/MouldingSIZEHead-band 29 cmVisor 32 x 22 cmWeight 53g
Made with Pride in UAE
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PPE designed to protect the wearer’s entire face from hazards and reduce potential infections.
Technical Specifications
Consumables
LIFE PLUSFACE SHIELD M2
Products
Model Face Shield M2MATERIALHead-band PU FoamVisor Anti-Fog PETTECHNOLOGY NA-Foam applied on the PETSIZEHead-band 3 x 3 x 27 cmVisor 32 x 19.5 cmWeight 31g
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Specifications
Intubation Box• The capsule is designed to protect health workers performing
intubation and extubation procedures on patients • The self-contained capsule fits over a patient’s head and
shoulders. A plastic curtain on the front allows access to the patient’s chest to apply CPR, if needed
• The negative pressure pump creates negative pressure inside the capsule, which expels contaminated air through a filter
• The capsule is made of seven parts. Assembly of parts takes only 10 minutes and does not require any tooling
• Two sizes are available: the ‘Mini-Capsule’ designed for ward beds and the ‘Mini-Capsule S’ designed for ER beds
Sterilisation of the capsule • Safe to clean using bleach products and UV cleaning
Medical Device
LIFE PLUSMINI-CAPSULE
Products
MINI-CAPSULE
Standard size of the Mini-Capsule
Smaller version of the Mini-Capsule
Standard size of the Mini-Capsule, alongwith a negativepressure pump
MINI-CAPSULE S MINI-CAPSULEPLUS
Made with Pride in UAE
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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention (CDC)
NIOSH Reference: TN-24039Mfr. Reference: NOR2020-2499
(Changes from original in bold)(Original enclosures are not included)
Ms. Edna deMedeirosRegulatory Compliance and Test ManagerHoneywell International2000 Plainfield PikeCranston, Rhode Island 02921
Dear Ms. deMedeiros:
The National Institute for Occupational Safety and Health (NIOSH) has reviewed your request accepted July 2, 2020. This request was for extension of approval TC-84A-8480 for the model H910 Plus Flatfold N95 air-purifying filtering facepiece respirator. The request is to addMexicali, Mexico and Al Ain, United Arab Emirates (UAE) as manufacturing sites. The part number for the Mexico made respirator is DF300N95 and will be available for sale in North America. The part number for the UAE made respirator is H919 and will be sold primarily in Middle East regions. The user instructions and Process Quality Plan (PQP) are updated accordingly. The complete respirator configurations are detailed on assembly matrix, file name H910PlusSeriesAMb.xls, revision B, dated: July 1, 2020.
This request is granted. Approvals are granted only for documentation written in the English language. It is the manufacturer’s responsibility to correctly translate materials desired in languages other than English.
The approval label is included as an attachment to this letter. The abbreviated labels have been accepted as submitted. The cautions and limitations are listed on the approval label. Only those assemblies affected by this request, or where new approval numbers are assigned, apply to thisapproval action. Production approval labels cannot include information on unapproved configurations.
The approved assemblies consist of the parts as listed on the approval labels and the assembly matrix. Parts are to be marked with the numbers indicated on the approval labels in a legible and permanent manner (marking cannot be removed without evidence of its previous presence).
National Institute for OccupationalSafety and Health (NIOSH)
National Personal Protective Technology Laboratory (NPPTL)
626 Cochrans Mill RoadPittsburgh, PA 15236-0070Phone: 412-386-4000Fax: 412-386-4051July 29, 2020
Certificates
H919 N95 NIOSH
Page 2 – Ms. Edna deMedeiros– TN-24039
No changes may be made to any respirators and accompanying documentation without prior written approval of NIOSH. Requests for changes must be submitted to NIOSH and a modification of this approval must be granted before changes are made.
Sincerely,
Jeffrey PetersonChief, Conformity Verification and Standards Development Branch
Enclosures
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Certificates
H910 PLUS FFP2
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#WeAreDedicated
MADE WITH PRIDE IN THE UAE
Strata Manufacturing PJSC Nibras Al Ain Aerospace Park,PO Box 86519 Al Ain,Emirate of Abu Dhabi,United Arab Emirates+971 3 7071 [email protected]
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www.strata.ae