Elara Brands

GUDID 20847212008387

Nitrile Examination Gloves, 3 Gram, Blue, Size L

Elara Foodservice Disposables LLC

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

• Primary Device ID: 20847212008387
• NIH Device Record Key: ed324a4d-9525-42c2-ae6b-6b02deb6b7d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elara Brands
• Version Model Number: MN103
• 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	00847212008383 [Primary]
GS1	20847212008387 [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 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