American Health and Safety GN620-1

GUDID 20850020922561

American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, Small, Case of 10 Packs

Labsource, Inc.

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

• Primary Device ID: 20850020922561
• NIH Device Record Key: c8d61077-5f66-4da9-8551-f0bd1c143913
• Commercial Distribution Discontinuation: 2033-08-16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: American Health and Safety
• Version Model Number: GN620-1
• Catalog Number: GN620-1
• Company DUNS: 199668690
• Company Name: Labsource, 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850020922567 [Unit of Use]
GS1	10850020922564 [Primary]
GS1	20850020922561 [Package]; Contains: 00850020922567; Package: Case [10 Units]; Discontinued: 2033-08-16; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222815

FDA Product Code

• OPJ: Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

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: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [American Health and Safety]

• 20850020922608: American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, 2X-Large,
• 20850020922592: American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, X-Large, C
• 20850020922585: American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, Large, Cas
• 20850020922578: American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, Medium, Ca
• 20850020922561: American Health and Safety™ Zircon™ EX Blue Disposable Nitrile Exam Grade Gloves, Small, Cas