Uline 5 Mil Latex Exam Gloves-L

GUDID 30850015055028

Size Large

ULINE, INC.

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

• Primary Device ID: 30850015055028
• NIH Device Record Key: 5fb4cf6e-1e5f-46af-bd55-676566d4764f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uline 5 Mil Latex Exam Gloves-L
• Version Model Number: S-9642L
• Company DUNS: 039612668
• Company Name: ULINE, 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850015055027 [Unit of Use]
GS1	10850015055024 [Primary]
GS1	30850015055028 [Package]; Contains: 10850015055024; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001280

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: 2020-10-27
• Device Publish Date: 2020-10-19

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