Criterion CL Glove PF Latex 1028296

GUDID 20304040110076

Criterion CL Glove PF Latex Small

HENRY SCHEIN, INC.

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

• Primary Device ID: 20304040110076
• NIH Device Record Key: 6319543f-bf15-489e-8a04-ce3056c4c415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Criterion CL Glove PF Latex
• Version Model Number: 1028296
• Catalog Number: 1028296
• 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	00304040110072 [Unit of Use]
GS1	10304040110079 [Primary]
GS1	20304040110076 [Package]; Contains: 10304040110079; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981917

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: 2020-01-16
• Device Publish Date: 2020-01-08

On-Brand Devices [Criterion CL Glove PF Latex]

• 20304040110076: Criterion CL Glove PF Latex Small
• 20304040110069: Criterion CL Glove PF Latex X-Small
• 20304040110052: Criterion CL Glove PF Latex Medium
• 20304040110045: Criterion CL Glove PF Latex X-Large
• 20304040110038: Criterion CL Glove PF Latex Large