Nephron Nitrile

GUDID 20850045437934

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

Nephron Nitrile LLC

Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered Nitrile surgical glove, non-powdered

Primary Device ID	20850045437934
NIH Device Record Key	2dced974-df77-4cc9-af68-c5a02273ca5c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nephron Nitrile
Version Model Number	200203003
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	00850045437930 [Primary]
GS1	10850045437937 [Unit of Use]
GS1	20850045437934 [Package] Contains: 00850045437930 Package: Case [10 Units] In Commercial Distribution
GS1	30850045437931 [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	2024-05-06
Device Publish Date	2024-04-26

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

Trademark Results [Nephron Nitrile]

Mark Image Registration \| Serial	Company Trademark Application Date
NEPHRON NITRILE 97864159 not registered Live/Pending	Nephron Nitrile LLC 2023-03-30