microdot

GUDID 00847713000558

Nitrile powder free examination gloves.

Cambridge Sensors USA LLC

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

• Primary Device ID: 00847713000558
• NIH Device Record Key: eb1f6502-cec0-4436-b923-37f6af4b6af8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot
• Version Model Number: 1204-10
• 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	00847713000459 [Primary]
GS1	00847713000466 [Package]; Contains: 00847713000459; Package: Box [10 Units]; In Commercial Distribution
GS1	00847713000558 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182554
• Premarket Notification: K222815

FDA Product Code

• FMC: Patient Examination Glove
• QDO: Fentanyl And Other Opioid Protection 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: 2022-12-01
• Device Publish Date: 2022-11-23

On-Brand Devices [microdot]

• 00847713000558: Nitrile powder free examination gloves.
• 00847713000435: Nitrile powder free examination gloves.
• 00847713000411: Nitrile powder free examination gloves.
• 00847713000398: Nitrile powder free examination gloves.
• 00847713000510: 1205-10