Illusion Glove PF Bubble Gum 1042056

GUDID 20304040101395

Illusion Glove PF Bubble Gum Small

HENRY SCHEIN, INC.

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

• Primary Device ID: 20304040101395
• NIH Device Record Key: 5f3dc717-12df-456b-8523-75f8a45ba4bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illusion Glove PF Bubble Gum
• Version Model Number: 1042056
• Catalog Number: 1042056
• 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	00304040101391 [Unit of Use]
GS1	10304040101398 [Primary]
GS1	20304040101395 [Package]; Contains: 10304040101398; 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 Bubble Gum]

• 20304040101418: Illusion Glove PF Bubble Gum Large
• 20304040101425: Illusion Glove PF Bubble Gum X-Large
• 20304040101401: Illusion Glove PF Bubble Gum Medium
• 20304040101395: Illusion Glove PF Bubble Gum Small
• 20304040101388: Illusion Glove PF Bubble Gum X-Small