FDA.reportPublic FDA data

AURELIA ROBUST

Primary DI
09555002102241
Brand
AURELIA ROBUST
Company
SUPERMAX GLOVE MANUFACTURING SDN. BHD.
Model
93899
Device description
Non-sterile Powder Free Nitrile Examination Gloves
Published
2024-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
09555002102241PrimaryGS10
19555002102248Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09555002102241095550021022419555002102241
1955500210224819555002102248

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
652680414
Device count
100
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09555002101053AURELIA VIBRANT982252024-02-08
09555002101060AURELIA VIBRANT982262024-02-08
09555002101077AURELIA VIBRANT982272024-02-08
09555002101084AURELIA VIBRANT982282024-02-08
09555002101091AURELIA VIBRANT982292024-02-08
09555002101404AURELIA DISTINCT292252024-02-08
09555002101411AURELIA DISTINCT292262024-02-08
09555002101428AURELIA DISTINCT292272024-02-08
09555002101435AURELIA DISTINCT292282024-02-08
09555002101442AURELIA DISTINCT292292024-02-08
09555002101558AURELIA REFRESH992252024-02-08
09555002101565AURELIA REFRESH992262024-02-08
09555002101572AURELIA REFRESH992272024-02-08
09555002101589AURELIA REFRESH992282024-02-08
09555002101596AURELIA REFRESH992292024-02-08
09555002102203AURELIA ROBUST938952024-02-08
09555002102210AURELIA ROBUST938962024-02-08
09555002102227AURELIA ROBUST938972024-02-08
09555002102234AURELIA ROBUST938982024-02-08
09555002102302AURELIA PROTEGE939952024-02-08

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Primary DI, Brand, Company table
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D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
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D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
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D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
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D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
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D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
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00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
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