AURELIA VIBRANT

GUDID 19555002101098

Non-sterile Powder Free Latex Examination Gloves

SUPERMAX GLOVE MANUFACTURING SDN. BHD.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID19555002101098
NIH Device Record Keyc973bffa-f101-44b6-a28e-78671bac45da
Commercial Distribution StatusIn Commercial Distribution
Brand NameAURELIA VIBRANT
Version Model Number98229
Company DUNS652680414
Company NameSUPERMAX GLOVE MANUFACTURING SDN. BHD.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109555002101091 [Primary]
GS119555002101098 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYYLatex Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-16
Device Publish Date2024-02-08

On-Brand Devices [AURELIA VIBRANT]

19555002101098Non-sterile Powder Free Latex Examination Gloves
19555002101081Non-sterile Powder Free Latex Examination Gloves
19555002101074Non-sterile Powder Free Latex Examination Gloves
19555002101067Non-sterile Powder Free Latex Examination Gloves
19555002101050Non-sterile Powder Free Latex Examination Gloves

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