Wise Choice

GUDID 00810073734999

Vinyl Powder-Free Exam Gloves - XL

Vanguard International Solutions, LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00810073734999
• NIH Device Record Key: 3c90fda5-33e4-41ff-8845-f87c5bb3a6ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wise Choice
• Version Model Number: 34104
• Company DUNS: 093129027
• Company Name: Vanguard International Solutions, LLC
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810073734982 [Primary]
GS1	00810073734999 [Package]; Contains: 00810073734982; Package: Box [100 Units]; In Commercial Distribution
GS1	00810073735002 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113837

FDA Product Code

• LYZ: Vinyl 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: 2024-08-16
• Device Publish Date: 2024-08-08

On-Brand Devices [Wise Choice]

• 00810073734999: Vinyl Powder-Free Exam Gloves - XL
• 00810073734968: Vinyl Powder-Free Exam Gloves - LG
• 00810073734937: Vinyl Powder-Free Exam Gloves - MD
• 00810073734906: Vinyl Powder-Free Exam Gloves - SM
• 00810073734876: Nitrile Powder-Free Exam Gloves - XL
• 00810073734845: Nitrile Powder-Free Exam Gloves - LG
• 00810073734814: Nitrile Powder-Free Exam Gloves - MD
• 00810073734784: Nitrile Powder-Free Exam Gloves - SM