Uline Safe-Flex 6 Mil Nitrile Glove - X

GUDID 30851253007732

ULINE, INC.

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

• Primary Device ID: 30851253007732
• NIH Device Record Key: c9d3d5c2-b60f-4287-97a1-f570f0321e29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uline Safe-Flex 6 Mil Nitrile Glove - X
• Version Model Number: S-21573-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	00851253007731 [Unit of Use]
GS1	10851253007738 [Primary]
GS1	30851253007732 [Package]; Contains: 10851253007738; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183354

FDA Product Code

• QDO: Fentanyl And Other Opioid Protection 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: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [Uline Safe-Flex 6 Mil Nitrile Glove - X]

• 30851253007398: Gloves Size X-Large
• 30851253007732: S-21573-X