Illusion Glove PF Latex Grape 1032700

GUDID 20304040101289

Illusion Glove PF Latex Grape X-Small

HENRY SCHEIN, INC.

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

• Primary Device ID: 20304040101289
• NIH Device Record Key: af38358b-5025-4453-b736-f48bc5e4a839
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illusion Glove PF Latex Grape
• Version Model Number: 1032700
• Catalog Number: 1032700
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 100
• DM Exempt: true
• 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: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *FALSE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040101285 [Unit of Use]
GS1	10304040101282 [Primary]
GS1	20304040101289 [Package]; Contains: 10304040101282; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103650

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: 2020-01-03
• Device Publish Date: 2019-12-26

On-Brand Devices [Illusion Glove PF Latex Grape]

• 20304040101357: Illusion Glove PF Latex Grape X-Large
• 20304040101340: Illusion Glove PF Latex Grape Large
• 20304040101333: Illusion Glove PF Latex Grape Medium
• 20304040101326: Illusion Glove PF Latex Grape Small
• 20304040101289: Illusion Glove PF Latex Grape X-Small