Vinyl Guard 6508-20

GUDID 10781311650821

disposable vinyl glove, powder-free, large, clear, 100 pk

Bunzl USA Holdings LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 10781311650821
• NIH Device Record Key: d589ddcf-0d41-431a-b0a6-389fd430c686
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vinyl Guard
• Version Model Number: 6508-20
• Catalog Number: 6508-20
• Company DUNS: 799540588
• Company Name: Bunzl USA Holdings 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10781311650821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072227

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: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [Vinyl Guard]

• 10781311650920: disposable vinyl glove, powder-free, xl, clear, 100 pk
• 10781311650821: disposable vinyl glove, powder-free, large, clear, 100 pk
• 10781311650722: disposable vinyl glove, powder-free, medium, clear, 100 pk
• 10781311650623: disposable vinyl glove, powder-free, small, clear, 100 pk