FDA.reportPublic FDA data

ARsoft

Primary DI
09555867100642
Brand
ARsoft
Company
ALLIANCE RUBBER PRODUCTS SDN. BHD.
Model
NGPF-05
Device description
5mils Powder Free Dark Green Nitrile Exam/Disposable Glove, Size XL
Published
2020-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19555867100649PackageGS110In Commercial Distribution
09555867100642PrimaryGS10
29555867100646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1955586710064919555867100649
09555867100642095558671006429555867100642
2955586710064629555867100646

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
604-5937616alliancerubber@alliancerubbe.com

Regulatory Flags#

DUNS number
652424177
Device count
100
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09555867100086Gold FingersLGPF-022020-01-24
09555867100093Gold FingersLGPF-022020-01-24
09555867100109Gold FingersLGPF-022020-01-24
09555867100116Gold FingersLGPF-022020-01-24
09555867100123Gold FingersLGPF-022020-01-24
09555867100130Safe PlusLGPF-042020-01-24
09555867100147Safe PlusLGPF-042020-01-24
09555867100154Safe PlusLGPF-042020-01-24
09555867100161Safe PlusLGPF-042020-01-24
09555867100178Safe PlusLGPF-042020-01-24
09555867100185ARsoftNGPF-012020-01-24
09555867100192ARsoftNGPF-012020-01-24
09555867100208ARsoftNGPF-012020-01-24
09555867100215ARsoftNGPF-012020-01-24
09555867100222ARsoftNGPF-012020-01-24
09555867100239ARsoftNGPF-012020-01-24
09555867100604ARsoftNGPF-052020-01-24
09555867100611ARsoftNGPF-052020-01-24
09555867100628ARsoftNGPF-052020-01-24
09555867100635ARsoftNGPF-052020-01-24

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Primary DI, Brand, Company table
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00850016052001NiTouchKasa Trading, LLCLZA2026-08-03
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00850016052056NiTouchKasa Trading, LLCLZA2026-08-03