UNC

GUDID 00850045738044

UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Large

The University of North Carolina Health System

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

• Primary Device ID: 00850045738044
• NIH Device Record Key: 977c5f34-df83-432e-94e5-29dac54408b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNC
• Version Model Number: GLVUNCL
• Company DUNS: 926678491
• Company Name: The University of North Carolina Health System
• Device Count: 200
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information
• Special Storage Condition, Specify: Between 0 and 0 *Labelling does not contain MRI Safety Information

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045738044 [Unit of Use]
GS1	10850045738041 [Primary]
GS1	20850045738048 [Package]; Contains: 10850045738041; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162923

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: 2022-11-14
• Device Publish Date: 2022-11-04

On-Brand Devices [UNC]

• 20850045738000: UNC Overhead SMS Gown, Thumbloops, Open Back, Yellow, Universal
• 00850045738051: UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, X-Large
• 00850045738044: UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Large
• 00850045738037: UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Medium
• 00850045738020: UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, Small
• 00850045738013: UNC, Powder Free, Nitrile, Examination Glove, Violet Blue, X-Small
• 20850045738062: UNC Overhead SMS Gown, Thumbloops with Elastic Cuff, Open Back, Yellow, Universal