Ext Cuff 12 Mil Latex Gloves-XL

GUDID 30851253007954

Size Extra Large

ULINE, INC.

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

• Primary Device ID: 30851253007954
• NIH Device Record Key: d5290ac0-50a2-4179-8b9e-74823f27b0b4
• Commercial Distribution Discontinuation: 2020-04-29
• Commercial Distribution Status: Not 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	00851253007953 [Unit of Use]
GS1	10851253007950 [Primary]
GS1	30851253007954 [Package]; Contains: 10851253007950; Package: [10 Units]; Discontinued: 2020-04-29; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982877

FDA Product Code

• LYY: Latex Patient Examination Glove

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-30
• Device Publish Date: 2020-04-15

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

• 30851253007954: Size Extra Large
• 30850015055097: Sub Item Number