Sterile Nitrile Surgical Gloves

GUDID 00616784653716

Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size 8

DYNAREX CORPORATION

Nitrile surgical glove, non-powdered

• Primary Device ID: 00616784653716
• NIH Device Record Key: 928d883c-e801-4ed5-94b9-c7c052409638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile Nitrile Surgical Gloves
• Version Model Number: 6537
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784653716 [Primary]
GS1	00616784653723 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	00616784653730 [Package]; Contains: 00616784653723; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122557

FDA Product Code

• KGO: Surgeon'S Gloves

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-02
• Device Publish Date: 2022-04-22

On-Brand Devices [Sterile Nitrile Surgical Gloves]

• 00616784653914: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
• 00616784653815: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
• 00616784653716: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
• 00616784653617: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
• 00616784653518: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
• 00616784653419: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size
• 00616784653310: Sterile Nitrile Surgical Gloves, Cuffed and Powder-Free, 1 Pair per Package, Hand Specific, Size