microdot

GUDID 00847713000435

Nitrile powder free examination gloves.

Cambridge Sensors USA LLC

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

• Primary Device ID: 00847713000435
• NIH Device Record Key: 471ed003-2234-4ee7-86ea-4f716e089075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microdot
• Version Model Number: 1203-10
• 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	00847713000435 [Primary]
GS1	00847713000442 [Package]; Package: Box [10 Units]; In Commercial Distribution
GS1	00847713000541 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182554
• Premarket Notification: K222815

FDA Product Code

• FMC: Patient Examination Glove
• LZC: Patient Examination 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: 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