Nitrile Gloves, Powder Free

GUDID 00810180843850

Nitrile Gloves, Powder-Free, Large, 2 Pair per package

Dynarex Corporation

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

• Primary Device ID: 00810180843850
• NIH Device Record Key: e85ad820-1597-4c4e-812e-f88cf0761f87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nitrile Gloves, Powder Free
• Version Model Number: 2619
• 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	00616784261911 [Primary]
GS1	00616784261935 [Package]; Contains: 00616784261911; Package: Case [500 Units]; In Commercial Distribution
GS1	00810180843850 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123869

FDA Product Code

• LZA: Polymer Patient Examination Glove

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2026-03-02
• Device Publish Date: 2022-04-22

On-Brand Devices [Nitrile Gloves, Powder Free]

• 00616784261904: Nitrile Gloves, Powder-Free, Large, 2 Pair per package
• 00616784261812: Nitrile Gloves, Powder-Free, Large, 1 Pair per package
• 00810180843850: Nitrile Gloves, Powder-Free, Large, 2 Pair per package