Velvet Touch

GUDID 00850053649172

Latex Examination Powder Free Gloves - Large

Mrglovz.com LLC

Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial

• Primary Device ID: 00850053649172
• NIH Device Record Key: 567d4e8f-328a-4eaa-ab42-f78085eecff0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velvet Touch
• Version Model Number: Large
• Company DUNS: 127613863
• Company Name: Mrglovz.com 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850053649127 [Unit of Use]
GS1	00850053649165 [Primary]
GS1	00850053649172 [Package]; Contains: 00850053649165; Package: Master Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202377

FDA Product Code

• LYY: Latex 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: 2023-06-28
• Device Publish Date: 2023-06-20

On-Brand Devices [Velvet Touch]

• 00850053649219: Blue Nitrile Examination Gloves Powder Free Small
• 00850053649196: Latex Examination Powder Free Gloves - Extra Large
• 00850053649172: Latex Examination Powder Free Gloves - Large
• 00850053649158: Latex Examination Powder Free Gloves - Medium
• 00850053649110: Latex Examination Powder Free Gloves - Small
• 00850053649073: Blue Nitrile Examination Gloves Powder Free Xtra-Large
• 00850053649226: Blue Nitrile Examination Gloves Powder Free Large
• 00850053649233: Blue Nitrile Examination Gloves Powder Free Medium