AmerCareRoyal Powder-Free Nitrile Exam Gloves

GUDID 00811033012423

Amercareroyal, LLC

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

• Primary Device ID: 00811033012423
• NIH Device Record Key: 20242c04-afde-497c-9062-84a61551aa06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmerCareRoyal Powder-Free Nitrile Exam Gloves
• Version Model Number: 14000
• 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	00811033012423 [Package]; Contains: 00811033012478; Package: Carton [10 Units]; In Commercial Distribution
GS1	00811033012478 [Primary]

FDA Product Code

• LZA: Polymer 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 Powder-Free Nitrile Exam Gloves]

• 00811033014892: 14005
• 00811033012461: 14004
• 00811033012454: 14003
• 00811033012447: 14002
• 00811033012430: 14001
• 00811033012423: 14000