VitalGard® Vinyl

GUDID 00649531920144

Vinyl Exam Glove, Clear, Medium

Dash Medical Gloves, Inc.

Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00649531920144
• NIH Device Record Key: bb48c6e5-dfbd-41fb-9244-4290a1445a20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalGard® Vinyl
• Version Model Number: VV100M
• Company DUNS: 194914768
• Company Name: Dash Medical Gloves, 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: false
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com
• Phone: 414-269-5298
• Email: compliancedepartment@dashmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00649531920144 [Package]; Contains: 00649531930143; Package: Case [10 Units]; In Commercial Distribution
GS1	00649531930044 [Unit of Use]
GS1	00649531930143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131832

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: 2022-09-30
• Device Publish Date: 2022-09-22

On-Brand Devices [VitalGard® Vinyl]

• 00649531920175: Vinyl Exam Glove, Clear, X-Large
• 00649531920168: Vinyl Exam Glove, Clear, Large
• 00649531920144: Vinyl Exam Glove, Clear, Medium
• 00649531920120: Vinyl Exam Glove, Clear, Small