microdot® Flex Black

GUDID 00847713001494

microdot® Flex Black Nitrile X-Large Gloves

Cambridge Sensors USA LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00847713001494
• NIH Device Record Key: 9586ef64-47d3-46f9-b974-58820b984336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot® Flex Black
• Version Model Number: 1604-10
• Company DUNS: 962314360
• Company Name: Cambridge Sensors USA LLC
• 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: true
• 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	00847713001418 [Unit of Use]
GS1	00847713001456 [Primary]
GS1	00847713001494 [Package]; Contains: 00847713001456; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222294

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: 2025-12-22
• Device Publish Date: 2025-12-12

On-Brand Devices [microdot® Flex Black]

• 00847713001494: microdot® Flex Black Nitrile X-Large Gloves
• 00847713001487: microdot® Flex Black Nitrile Large Gloves
• 00847713001470: microdot® Flex Black Nitrile Medium Gloves
• 00847713001463: microdot® Flex Black Nitrile Small Gloves