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

GUDID 00840117334151

DYNAREX CORPORATION

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

• Primary Device ID: 00840117334151
• NIH Device Record Key: ac28ac2d-95c2-406f-a068-3d2582c62b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dyna-Safety Nitrile Exam Gloves,Powder-Free,Blue,X-Large
• Version Model Number: 2624
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: 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	00840117334144 [Primary]
GS1	00840117334151 [Package]; Contains: 00840117334144; Package: MC Master [500 Units]; In Commercial Distribution

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: 2024-03-26
• Device Publish Date: 2024-03-18

Devices Manufactured by DYNAREX CORPORATION

• 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3": 2024-11-19
• 00840117341210 - Medicine Cups 1oz: 2024-11-05
• 00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm: 2024-11-01 Sterile-EO
• 00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm: 2024-11-01 Sterile-EO
• 00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm: 2024-11-01 Sterile-EO
• 00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm: 2024-11-01 Sterile-Eo
• 00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm: 2024-11-01 Sterile-Eo
• 00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm: 2024-11-01 Sterile-Eo