Guardian

GUDID D77116100LG0

Guardian PF Latex Gloves Large

ICP, INC.

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

• Primary Device ID: D77116100LG0
• NIH Device Record Key: 285fae3b-fc64-427b-bddb-8e61a2cc8d92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardian
• Version Model Number: 16-100LG
• Company DUNS: 808371371
• Company Name: ICP, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77116100LG0 [Unit of Use]
HIBCC	D77116100LG1 [Primary]

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: 2026-03-27
• Device Publish Date: 2026-03-19

On-Brand Devices [Guardian]

• D77116100XS0: Guardian PF Latex Gloves X-Small
• D77116100XL0: Guardian PF Latex Gloves X-Large
• D77116100SM0: Guardian PF Latex Gloves Small
• D77116100MD0: Guardian PF Latex Gloves Medium
• D77116100LG0: Guardian PF Latex Gloves Large