AmerCareRoyal Chameleon Powder-Free Synthetic Exam Gloves

GUDID 00811033010870

Amercareroyal, LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00811033010870
• NIH Device Record Key: 1ebcd4ab-ac8d-4892-ab86-2ce90f100432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmerCareRoyal Chameleon Powder-Free Synthetic Exam Gloves
• Version Model Number: 12001
• Company DUNS: 002326965
• Company Name: Amercareroyal, LLC
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811033010863 [Primary]
GS1	00811033010870 [Package]; Contains: 00811033010863; Package: Carton [10 Units]; In Commercial Distribution

FDA Product Code

• LYZ: Vinyl 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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [AmerCareRoyal Chameleon Powder-Free Synthetic Exam Gloves]

• 00811033010931: 12004
• 00811033010900: 12003
• 00811033010894: 12002
• 00811033010870: 12001