AmerCareRoyal Sensi-Flex Powder-Free PVC Exam Gloves

GUDID 00811033010535

Amercareroyal, LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00811033010535
• NIH Device Record Key: a9f9ba75-660b-49b0-9be5-eb325f68bc5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AmerCareRoyal Sensi-Flex Powder-Free PVC Exam Gloves
• Version Model Number: 5003
• 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	00811033010528 [Primary]
GS1	00811033010535 [Package]; Contains: 00811033010528; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100339

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 Sensi-Flex Powder-Free PVC Exam Gloves]

• 00842312128474: VINFRXLCPK
• 00842312128450: VINFRLCPK
• 00842312128436: VINFRMCPK
• 00842312128412: VINFRSCPK
• 00811033010559: 5004
• 00811033010535: 5003
• 00811033010511: 5002
• 00811033010498: 5001