Black Talon 70-0001

GUDID 30842209133278

GLOVES, BLACK NITRILE - SMALL (Box of 100)

NORTH AMERICAN RESCUE, LLC

Nitrile surgical glove, non-powdered

• Primary Device ID: 30842209133278
• NIH Device Record Key: f109fa3a-b031-4cbc-94ba-e5eaac91eb05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Talon
• Version Model Number: 70-0001
• Catalog Number: 70-0001
• Company DUNS: 832426782
• Company Name: NORTH AMERICAN RESCUE, LLC
• 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: 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	00842209133277 [Primary]
GS1	10842209133274 [Unit of Use]
GS1	30842209133278 [Package]; Contains: 00842209133277; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232654

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: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [Black Talon]

• 10842209132116: GLOVES, BLACK NITRILE - XLARGE (1000 pack)
• 10842209133274: GLOVES, BLACK NITRILE - SMALL (1000 pack)
• 30842209133278: GLOVES, BLACK NITRILE - SMALL (Box of 100)