Elara Brand

GUDID 20847212008363

Nitrile Examination Gloves, 3 Gram, Blue, Size Small

Elara Foodservice Disposables LLC

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

• Primary Device ID: 20847212008363
• NIH Device Record Key: 1393fd0c-3485-4037-99d8-6dd4a53d7621
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elara Brand
• Version Model Number: MN101
• Company DUNS: 010850179
• Company Name: Elara Foodservice Disposables LLC
• Device Count: 100
• DM Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847212008369 [Primary]
GS1	20847212008363 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214110

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: 2024-02-13
• Device Publish Date: 2024-02-05

On-Brand Devices [Elara Brand]

• 20847212008370: Nitrile Examination Gloves, 3 Gram, Blue, Size Medium
• 20847212008363: Nitrile Examination Gloves, 3 Gram, Blue, Size Small