PremierPro D5064

GUDID 10811220035461

PremierPro Plus Powered by Honeywell Nitrile Exam Glove Large 200count

SVS LLC

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

• Primary Device ID: 10811220035461
• NIH Device Record Key: 720e7e74-56e3-41cd-a0ef-2730dab35016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremierPro
• Version Model Number: D5064
• Catalog Number: D5064
• Company DUNS: 831375089
• Company Name: SVS 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: true
• 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

Customer Support Contacts

• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com
• Phone: 1-855-531-7699
• Email: info@s2s-global.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811220035464 [Primary]
GS1	10811220035461 [Package]; Contains: 00811220035464; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220825

FDA Product Code

• LZC: Patient Examination Glove, Specialty

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: 2024-03-18
• Device Publish Date: 2024-03-08

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