Cool Blue™ Nitrile Gloves GLV-CB-L

GUDID 10860008768237

Cool Blue™ Nitrile Gloves, Powder Free, Large

Stellar Scientific, LLC

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

• Primary Device ID: 10860008768237
• NIH Device Record Key: 35fea187-7779-45fb-9328-d29cd7ff09a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cool Blue™ Nitrile Gloves
• Version Model Number: GLV-CB-L
• Catalog Number: GLV-CB-L
• Company DUNS: 015714220
• Company Name: Stellar Scientific, 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: false
• 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

Customer Support Contacts

• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com
• Phone: 410-764-2225
• Email: cs@stellarscientific.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008768230 [Primary]
GS1	10860008768237 [Package]; Contains: 00860008768230; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202003

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: 2022-08-10
• Device Publish Date: 2022-08-02

On-Brand Devices [Cool Blue™ Nitrile Gloves]

• 10860008768244: Cool Blue™ Nitrile Gloves, Powder Free, Medium
• 10860008768237: Cool Blue™ Nitrile Gloves, Powder Free, Large
• 10860008768206: Cool Blue™ Nitrile Gloves, Powder Free, Small