microdot® Pro Gloves

GUDID 00847713001005

microdot® Pro Nitrile Large Gloves

Cambridge Sensors USA LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 00847713001005
• NIH Device Record Key: 025de54e-3b22-4027-a013-4a06f9846b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot® Pro Gloves
• Version Model Number: 1403-10
• 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	00847713000909 [Unit of Use]
GS1	00847713000954 [Primary]
GS1	00847713001005 [Package]; Contains: 00847713000954; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222376

FDA Product Code

• LZC: Medical Glove, Specialty

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: 2025-02-26
• Device Publish Date: 2025-02-18

On-Brand Devices [microdot® Pro Gloves]

• 00847713001029: microdot® Pro Nitrile XX-Large Gloves
• 00847713001012: microdot® Pro Nitrile X-Large Gloves
• 00847713001005: microdot® Pro Nitrile Large Gloves
• 00847713000992: Microdot® Pro Nitrile Medium Gloves
• 00847713000985: Microdot® Pro Nitrile Small Gloves