Nephron Nitrile

GUDID 20850045437965

Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) XXL

Nephron Nitrile LLC

Nitrile surgical glove, non-powdered

• Primary Device ID: 20850045437965
• NIH Device Record Key: 7ba1db9c-2a73-434d-88cb-76ec2ad85cb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nephron Nitrile
• Version Model Number: 200206006
• Company DUNS: 118398628
• Company Name: Nephron Nitrile 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: 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	00850045437961 [Primary]
GS1	10850045437968 [Unit of Use]
GS1	20850045437965 [Package]; Contains: 00850045437961; Package: Case [10 Units]; In Commercial Distribution
GS1	30850045437962 [Package]; Package: Pallet [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232654

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: 2024-06-07
• Device Publish Date: 2024-05-30

On-Brand Devices [Nephron Nitrile]

• 20850045437958: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemothera
• 20850045437941: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemothera
• 20850045437934: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemothera
• 20850045437927: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemothera
• 20850045437910: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemothera
• 20850045437965: Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemothera