Elara Brands

GUDID 20847212008493

Nitrile examination gloves, black, 3 gram, size medium

Elara Foodservice Disposables LLC

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

• Primary Device ID: 20847212008493
• NIH Device Record Key: 4f1500e4-6b91-4933-ac16-4b0a7de22250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elara Brands
• Version Model Number: MND202BK
• Company DUNS: 010850179
• Company Name: Elara Foodservice Disposables 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: 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	00847212008499 [Primary]
GS1	20847212008493 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230002

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: 2024-05-22
• Device Publish Date: 2024-05-14

On-Brand Devices [Elara Brands]

• 20847212008431: Nitrile Examination Gloves, Black, 3 Gram, Size XL
• 20847212008424: Nitrile Examination Gloves, Black, 3 Gram, Size Large
• 20847212008417: Nitrile Examination gloves, Black, 3 Gram, size medium
• 20847212008400: Nitrile Examination Gloves, Black, 3 Gram, size small
• 20847212008394: Nitrile Examination Gloves, Blue, 3 Gram, Size XL
• 20847212008387: Nitrile Examination Gloves, 3 Gram, Blue, Size L
• 20847212007939: Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size x-large
• 20847212007922: Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size large
• 20847212007915: Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size medium
• 20847212007908: Synthetic Hybrid Examination Gloves, vinyl nitrile blend, blue, size small
• 20847212008516: nitrile examination gloves, black, 3 gram, size x-large
• 20847212008509: Nitrile examination gloves, black, 3 gram, size large
• 20847212008493: Nitrile examination gloves, black, 3 gram, size medium
• 20847212008486: Nitrile exam gloves, black, 3 gram, size small
• 20847212008479: Nitrile examination gloves, blue, 3 gram, size x-large
• 20847212008462: Nitrile examination gloves, blue, 3 gram, size large
• 20847212008455: Nitrile examination gloves, blue, 3 gram, size medium
• 20847212008448: Nitrile Examination Gloves, Blue, 3 gram, size small