AmerCareRoyal Response ER Powder-Free Latex Exam Gloves

GUDID 00811033010818

Amercareroyal, LLC

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

• Primary Device ID: 00811033010818
• NIH Device Record Key: 9d314f1c-ccf6-4618-8d44-6c0b6ff76260
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmerCareRoyal Response ER Powder-Free Latex Exam Gloves
• Version Model Number: 8004
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811033010801 [Primary]
GS1	00811033010818 [Package]; Contains: 00811033010801; Package: Carton [10 Units]; In Commercial Distribution

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

On-Brand Devices [AmerCareRoyal Response ER Powder-Free Latex Exam Gloves]

• 00811033010856: 8001
• 00811033010832: 8005
• 00811033010818: 8004
• 00811033010795: 8003
• 00811033010771: 8002