Uline Black Exam Nitrile Glvs-XL S-21081-X

GUDID 30851253007152

Size X-Large Gloves

ULINE, INC.

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

• Primary Device ID: 30851253007152
• NIH Device Record Key: 7e060626-1d66-4888-9540-67c55699e481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uline Black Exam Nitrile Glvs-XL
• Version Model Number: S-21081-X
• Catalog Number: S-21081-X
• Company DUNS: 039612668
• Company Name: ULINE, INC.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851253007151 [Unit of Use]
GS1	10851253007158 [Primary]
GS1	30851253007152 [Package]; Contains: 10851253007158; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070096

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: 2019-04-17
• Device Publish Date: 2019-04-09

On-Brand Devices [Uline Black Exam Nitrile Glvs-XL]

• 30851253007152: Size X-Large Gloves
• 30850015055394: S-21081-X