Jet Black Supply

GUDID 03630148904938

Individual box, X LARGE

Nexus Brands Group, Inc.

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

• Primary Device ID: 03630148904938
• NIH Device Record Key: a54e0c54-f275-4be9-90d2-cc1a10eca988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jet Black Supply
• Version Model Number: JBS-35G-XLARGE
• Company DUNS: 045458013
• Company Name: Nexus Brands Group, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00630148663845 [Package]; Contains: 00630148904931; Package: [10 Units]; In Commercial Distribution
GS1	00630148904931 [Primary]
GS1	03630148904938 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213843

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: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [Jet Black Supply]

• 03630148904938: Individual box, X LARGE
• 00630148663838: Individual box, LARGE
• 00630148663821: Individual box, MEDIUM
• 00630148663814: Individual box, SMALL