Empire

GUDID 00850030415516

Empire Managed Solutions LLC

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

• Primary Device ID: 00850030415516
• NIH Device Record Key: 56af44ab-2726-4103-a131-2be1340bb22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empire
• Version Model Number: 5.5 MIL Nitrile Gloves- Box
• Company DUNS: 117334642
• Company Name: Empire Managed Solutions LLC
• Device Count: 1
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030415516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133307

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: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [Empire]

• 00850030415547: 4 MIL Nitrile Gloves- Box
• 00850030415530: 5 MIL Nitrile Gloves- Box
• 00850030415523: 5.5 MIL Nitrile Gloves- Box
• 00850030415516: 5.5 MIL Nitrile Gloves- Box
• 00850030415486: 4 MIL Nitrile Gloves- Case
• 00850030415479: 4 MIL Nitrile Gloves- Case
• 00850030415462: 5.5 MIL Nitrile Gloves- Case
• 00850030415455: 5.5 MIL Nitrile Gloves- Case
• 00850030415448: 5.5 MIL Nitrile Gloves- Case
• 00850030415431: 5.5 MIL Nitrile Gloves- Case