GenaCheck® Nitrile Powder Free Examination Glove ZC8-E20100

GUDID 00810143620153

Genabio Diagnostics Inc.

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

• Primary Device ID: 00810143620153
• NIH Device Record Key: b8740d36-424b-4983-b724-9247b8bede4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GenaCheck® Nitrile Powder Free Examination Glove
• Version Model Number: N/A
• Catalog Number: ZC8-E20100
• Company DUNS: 118586095
• Company Name: Genabio Diagnostics 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00810143620153 [Primary]
GS1	81014362015300 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240545

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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-21
• Device Publish Date: 2025-01-13

On-Brand Devices [GenaCheck® Nitrile Powder Free Examination Glove]

• 00810143620153: N/A
• 00810143620146: N/A
• 00810143620139: N/A
• 00810143620115: N/A