EXT Cuff 12 Mil Latex Gloves-S

GUDID 30850015055080

Sub Item Number

ULINE, INC.

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

• Primary Device ID: 30850015055080
• NIH Device Record Key: 1670457a-9e51-45d6-9ef6-5cdbeada3740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXT Cuff 12 Mil Latex Gloves-S
• Version Model Number: S-17904S-S1
• Company DUNS: 039612668
• Company Name: ULINE, INC.
• Device Count: 50
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015055126 [Unit of Use]
GS1	10850015055123 [Primary]
GS1	30850015055080 [Package]; Contains: 10850015055123; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123819

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: 2020-12-31
• Device Publish Date: 2020-12-23

On-Brand Devices [EXT Cuff 12 Mil Latex Gloves-S]

• 30851253007947: Size Small
• 30850015055080: Sub Item Number