Ext Cuff 12 Mil Latex Gloves - XL

GUDID 30851253007770

Size Extra Large

ULINE, INC.

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

• Primary Device ID: 30851253007770
• NIH Device Record Key: c0b2233c-36f0-45c7-9605-a88b1d7d440e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ext Cuff 12 Mil Latex Gloves - XL
• Version Model Number: S-17904X
• 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	00851253007779 [Unit of Use]
GS1	10851253007776 [Primary]
GS1	30851253007770 [Package]; Contains: 10851253007776; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123819

FDA Product Code

• LZC: Patient Examination Glove, Specialty

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: 2019-12-13
• Device Publish Date: 2019-12-05

On-Brand Devices [Ext Cuff 12 Mil Latex Gloves - XL]

• 30851253007770: Size Extra Large
• 30851253007237: Extended Cuff Gloves Size X-Large