Uniseal High Risk Nitrile

GUDID 30744514101563

Nitrile Powder Free Textured Dark Blue Exam Gloves, Non- Sterile, Chemo Tested, NFPA, Extended length, Size S

Uniseal

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

• Primary Device ID: 30744514101563
• NIH Device Record Key: 4f4c28a2-9136-41a0-b7cd-b9ec72e07832
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uniseal High Risk Nitrile
• Version Model Number: 015X-6
• Company DUNS: 782209340
• Company Name: Uniseal
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	10744514101569 [Unit of Use]
GS1	20744514101566 [Primary]
GS1	30744514101563 [Package]; Contains: 20744514101566; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071119

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Uniseal High Risk Nitrile]

• 30744514101594: Nitrile Powder Free Textured Dark Blue Exam Gloves, Non-Sterile, Chemo Tested, NFPA, Extended le
• 30744514101587: Nitrile Powder Free Textured Dark Blue Exam Gloves, Non-Sterile, Chemo Tested, NFPA, Extended le
• 30744514101570: Nitrile Powder Free Textured Dark Blue Exam Gloves, Non-Sterile, Chemo Tested, NFPA, Extended le
• 30744514101563: Nitrile Powder Free Textured Dark Blue Exam Gloves, Non- Sterile, Chemo Tested, NFPA, Extended l
• 30744514101501: Nitrile Powder Free Textured Dark Blue Exam Gloves, Non-Sterile, Chemo Tested, NFPA, Extended le