AURELIA IGNITE

GUDID 19555002110229

Non-sterile Powder Free Nitrile Examination Gloves

SUPERMAX GLOVE MANUFACTURING SDN. BHD.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 19555002110229
• NIH Device Record Key: c4be82d5-eac9-4d4e-bb8a-4b8713c89e14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AURELIA IGNITE
• Version Model Number: 97889
• Company DUNS: 652680414
• Company Name: SUPERMAX GLOVE MANUFACTURING SDN. BHD.
• Device Count: 90
• 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: false
• Labeled No Natural Rubber Latex: true
• 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	09555002110222 [Primary]
GS1	19555002110229 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993258

FDA Product Code

• LZA: Polymer 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 IGNITE]

• 19555002110236: Non-sterile Powder Free Nitrile Examination Gloves
• 19555002110229: Non-sterile Powder Free Nitrile Examination Gloves
• 19555002110212: Non-sterile Powder Free Nitrile Examination Gloves
• 19555002110205: Non-sterile Powder Free Nitrile Examination Gloves