TRADEX INTERNATIONAL GEN271

GUDID 10699320497255

Nitrile Exam Blue Powder Free gloves M=3.5g XL

Cardinal Health 200, LLC

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

• Primary Device ID: 10699320497255
• NIH Device Record Key: e49c79fb-45b9-408f-83b5-16c6022a74ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRADEX INTERNATIONAL
• Version Model Number: GEN271
• Catalog Number: GEN271
• Company DUNS: 961027315
• Company Name: Cardinal Health 200, 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00699320497258 [Primary]
GS1	10699320497255 [Package]; Contains: 00699320497258; Package: CASE [10 Units]; In Commercial Distribution
GS1	70699320497257 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141279

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: 2019-07-31
• Device Publish Date: 2019-07-23

On-Brand Devices [TRADEX INTERNATIONAL]

• 10699320497255: Nitrile Exam Blue Powder Free gloves M=3.5g XL
• 10699320497248: Nitrile Exam Blue Powder Free gloves M=3.5g Large
• 10699320497231: Nitrile Exam Blue Powder Free gloves M=3.5g Medium
• 10699320497224: Nitrile Exam Blue Powder Free gloves M=3.5g Small
• 10699320492250: Nitrile Exam Blue Powder Free gloves M 4.5g, finger tip XL
• 10699320492243: Nitrile Exam Blue Powder Free gloves M=4.5g, finger tip Large
• 10699320492236: Nitrile Exam Blue Powder Free gloves M=4.5g, finger tip Medium
• 10699320492229: Nitrile Exam Blue Powder Free gloves M=4.5g, finger tip Small
• 10699320297053: Vinyl Exam Clear Powder Free Glove M=5.2g XL
• 10699320297046: Vinyl Exam Clear Powder Free Glove M=5.2g Large
• 10699320297039: Vinyl Exam Clear Powder Free Glove M=5.2g Medium
• 10699320297022: Vinyl Exam Clear Powder Free Glove M=5.2g Small