TGSS Nitrile

GUDID 10850052497108

5Mil Blue Nitrile Gloves, XL

Tony's Gloves & Safety Supply, Inc.

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

• Primary Device ID: 10850052497108
• NIH Device Record Key: d00b9b09-49dd-451e-b974-3d5a9ede997c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TGSS Nitrile
• Version Model Number: TG1262XL-V
• Company DUNS: 055429269
• Company Name: Tony's Gloves & Safety Supply, Inc.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• 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	00850052497101 [Primary]
GS1	10850052497108 [Package]; Contains: 00850052497101; Package: [10 Units]; In Commercial Distribution
GS1	20850052497075 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223444

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: 2024-03-18
• Device Publish Date: 2024-03-08