Dyna Safety Nitrile Exam Gloves, Powder Free, Blue, 2 pair, X-Large

GUDID 08401173341686

DYNAREX CORPORATION

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

• Primary Device ID: 08401173341686
• NIH Device Record Key: b5555c32-e851-4062-b50f-d0d5f69bbd94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dyna Safety Nitrile Exam Gloves, Powder Free, Blue, 2 pair, X-Large
• Version Model Number: 2625
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 2
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117334168 [Primary]
GS1	00840117334175 [Package]; Contains: 00840117334168; Package: Case [500 Units]; In Commercial Distribution
GS1	08401173341686 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121526

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: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [Dyna Safety Nitrile Exam Gloves, Powder Free, Blue, 2 pair, X-Large]

• 08401173341686: 2625
• 00810180840132: 2625