AURELIA REFRESH

GUDID 19555002101586

Non-sterile Powder Free Latex Examination Gloves

SUPERMAX GLOVE MANUFACTURING SDN. BHD.

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 19555002101586
• NIH Device Record Key: aae49bf1-eb44-4774-97f3-2a878b87da8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURELIA REFRESH
• Version Model Number: 99228
• Company DUNS: 652680414
• Company Name: SUPERMAX GLOVE MANUFACTURING SDN. BHD.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555002101589 [Primary]
GS1	19555002101586 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991415

FDA Product Code

• LYY: Latex Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [AURELIA REFRESH]

• 19555002101593: Non-sterile Powder Free Latex Examination Gloves
• 19555002101586: Non-sterile Powder Free Latex Examination Gloves
• 19555002101579: Non-sterile Powder Free Latex Examination Gloves
• 19555002101562: Non-sterile Powder Free Latex Examination Gloves
• 19555002101555: Non-sterile Powder Free Latex Examination Gloves