TGSS

GUDID 10850052497016

Blue Nitrile, M

Tony's Gloves & Safety Supply, Inc.

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

• Primary Device ID: 10850052497016
• NIH Device Record Key: fc453bf5-3a20-48b1-a642-e06f877e963e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TGSS
• Version Model Number: TG1262M
• 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	00850052497019 [Primary]
GS1	10850052497016 [Package]; Contains: 00850052497019; Package: [10 Units]; In Commercial Distribution
GS1	20850052497013 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112294

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: 2023-07-19
• Device Publish Date: 2023-07-11