Black Talon ZZ-0277

GUDID 10842209132116

GLOVES, BLACK NITRILE - XLARGE (1000 pack)

NORTH AMERICAN RESCUE, LLC

Nitrile surgical glove, non-powdered

• Primary Device ID: 10842209132116
• NIH Device Record Key: d9a7bcff-8ae1-4d0f-b77a-d074905ba634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Talon
• Version Model Number: ZZ-0277
• Catalog Number: ZZ-0277
• Company DUNS: 832426782
• Company Name: NORTH AMERICAN RESCUE, LLC
• Device Count: 1000
• 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	00842209132119 [Primary]
GS1	10842209132116 [Unit of Use]
GS1	20842209132113 [Primary]
GS1	30842209132110 [Package]; Contains: 00842209132119; Package: case [10 Units]; In Commercial Distribution
GS1	40842209132117 [Primary]

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: 2024-12-26
• Device Publish Date: 2024-12-18

Devices Manufactured by NORTH AMERICAN RESCUE, LLC

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• 00842209133703 - NAR: 2024-12-26
• 00842209133710 - NAR: 2024-12-26
• 00842209133727 - NAR: 2024-12-26
• 00842209133734 - NAR: 2024-12-26
• 00842209133741 - NAR: 2024-12-26
• 00842209133758 - NAR: 2024-12-26
• 00842209133765 - NAR: 2024-12-26