AURELIA DISTINCT

GUDID 19555002101425

Non-sterile Powder Free Latex Examination Gloves

SUPERMAX GLOVE MANUFACTURING SDN. BHD.

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

• Primary Device ID: 19555002101425
• NIH Device Record Key: 68646fab-8623-4041-85c8-3ea610ca2065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURELIA DISTINCT
• Version Model Number: 29227
• 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	09555002101428 [Primary]
GS1	19555002101425 [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 DISTINCT]

• 19555002101449: Non-sterile Powder Free Latex Examination Gloves
• 19555002101432: Non-sterile Powder Free Latex Examination Gloves
• 19555002101425: Non-sterile Powder Free Latex Examination Gloves
• 19555002101418: Non-sterile Powder Free Latex Examination Gloves
• 19555002101401: Non-sterile Powder Free Latex Examination Gloves