Armbrust

GUDID 85005644102500

USA Made Nitrile Gloves - Blue - Medium - Box of 100

Armbrust Inc.

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

• Primary Device ID: 85005644102500
• NIH Device Record Key: 379fd7f3-65bb-4e84-b2ec-360f3a8fde4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Armbrust
• Version Model Number: GLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X100-M
• Company DUNS: 117532009
• Company Name: Armbrust Inc.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com
• Phone: 512-807-0744
• Email: support@armbrust.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.
• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from freezing, avoid excessive heat, keep dry, shielded from direct sunlight, fluorescent lighting, e-rays, moisture and ozone.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850056441025 [Primary]
GS1	85005644102500 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222898

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: 2025-10-02
• Device Publish Date: 2025-09-24

On-Brand Devices [Armbrust]

• 85005644105600: USA Made Nitrile Gloves - Blue - Extra Extra Large - Box of 90
• 85005644104900: USA Made Nitrile Gloves - Blue - Extra Large- Box of 100
• 85005644103200: USA Made Nitrile Gloves - Blue - Large- Box of 100
• 85005644102500: USA Made Nitrile Gloves - Blue - Medium - Box of 100
• 85005644101800: USA Made Nitrile Gloves - Blue - Small- Box of 100
• 85005644100100: USA Made Nitrile Gloves - Blue - EXTRA SMALL- Box of 100